CMC Regulatory Affairs Pharmaceutical Industry Jobs in Hyderabad

210 Jobs Found

IN

Solution Consultant - Sap Eam

Innovapptive

5+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Position: Solution Consultant SAP EAM Location: Hyderabad, Telangana, India Employment Type: Full-Time, Salaried Compensation: Base Salary + Bonus + Benefits About Innovapptive: Innovapptive is transforming the industrial workforce by connecting front-line workers, back-office teams, and assets through the only patented, Code-Free connected worker platform for SAP and IBM Maximo. Our platform digitizes manual, paper-based processes in maintenance, operations, and supply chain with highly configurable mobile apps, giving real-time visibility and actionable insights to back-office teams. Trusted by global leaders like Newmont Mining, Shell, UNICEF, and Reckitt Benckiser, we save companies millions by improving asset uptime, productivity, safety, and workforce efficiency. Backed by Tiger Global Management and recently funded by Vista Equity Partners, Innovapptive is rapidly growing and committed to empowering 350 million industrial front-line workers worldwide. Role Overview: The Solution Consultant will engage directly with plant maintenance leaders to consult on value improvement, maturity assessments, process enhancements, and mobility best practices. You will lead solution design workshops, drive adoption of Innovapptive s cloud-based SaaS connected worker solutions, and support customers in achieving key operational KPIs such as: Efficient plant maintenance execution Timely maintenance work completion Compliance with regulatory and industry standards Key Responsibilities: Collaborate with customers and internal teams to gather and prioritize requirements, translating them into actionable product features. Lead solution design workshops and create value models demonstrating cost savings and operational improvements. Document test scenarios and maintain traceability matrices aligned with business requirements. Promote rapid, agile solution iterations ensuring quality, efficiency, and speed to value. Ensure delivery timelines and quality standards are met, driving ROI and user adoption post-implementation. Partner with product management to influence roadmap and feature prioritization. Analyze user personas to tailor solutions that alleviate core pain points of maintenance professionals. Develop training materials and documentation to empower end-users. Collaborate across engineering, design, marketing, and sales teams to ensure aligned product development. Embrace a startup mindset adaptable, resilient, and entrepreneurial. Qualifications & Experience: Bachelor s degree in Computer Science, IT, or related field. 5+ years as a solution engineer or functional expert in Smart Manufacturing / Connected Plant applications. 3+ years domain experience in Maintenance and Operations. Strong expertise in Plant Maintenance processes: Work Order Planning & Scheduling, Notifications, Execution, Functional Locations, Inspections, and Permits. Experience with full cycle project implementations is preferred. Excellent analytical, problem-solving, organizational, and communication skills. Self-motivated, able to work independently and within teams. Leadership experience and project coordination skills are a plus. Certifications like CCBA or CBAP are desirable. What We Offer: Collaborative, innovative, and entrepreneurial work environment Opportunities to work with global brands on impactful projects Competitive salary and benefits including medical insurance for family Paid maternity and paternity leave Generous vacation and paid time off Bi-annual performance reviews and transparent feedback culture Extensive learning and development resources Active interest groups and clubs (Book Reading, Toastmasters, Sports, Music) Innovapptive is an equal opportunity employer committed to diversity and inclusion. Qualified applicants will receive consideration without regard to protected characteristics under applicable law. Qualification : Bachelors degree in Computer Science, IT, or related field.

Solution Consultant Solution consultant SAP Sap solution
KS

Data Governance Lead

Kanerika Software

7+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Title: Data Governance Lead Job Location: Hyderabad Job Description As a Data Governance Lead at Kanerika, you will be responsible for defining, leading, and operationalizing the data governance framework, ensuring enterprise-wide alignment and regulatory compliance. Key Responsibilities: Governance Strategy & Stakeholder Alignment Develop and maintain enterprise data governance strategies, policies, and standards. Align governance with business goals: compliance, analytics, and decision-making. Collaborate across business, IT, legal, and compliance teams for role alignment. Drive governance training, awareness, and change management programs. Microsoft Purview Administration & Implementation Manage Microsoft Purview accounts, collections, and RBAC aligned to org structure. Optimize Purview setup for large-scale environments (50TB+). Integrate with Azure Data Lake, Synapse, SQL DB, Power BI, Snowflake. Schedule scans, set classification jobs, and maintain collection hierarchies. Metadata & Lineage Management Design metadata repositories and maintain business glossaries and data dictionaries. Implement ingestion workflows via ADF, REST APIs, PowerShell, Azure Functions. Ensure lineage mapping (ADF Synapse Power BI) and impact analysis. Data Classification & Security Governance Define classification rules and sensitivity labels (PII, PCI, PHI). Integrate with MIP, DLP, Insider Risk Management, and Compliance Manager. Enforce records management, lifecycle policies, and information barriers. Data Quality & Policy Management Define KPIs and dashboards to monitor data quality across domains. Collaborate on rule design, remediation workflows, and exception handling. Ensure policy compliance (GDPR, HIPAA, CCPA, etc.) and risk management. Business Glossary & Stewardship Maintain business glossary with domain owners and stewards in Purview. Enforce approval workflows, standard naming, and steward responsibilities. Conduct metadata audits for glossary and asset documentation quality. Automation & Integration Automate governance processes using PowerShell, Azure Functions, Logic Apps. Create pipelines for ingestion, lineage, glossary updates, tagging. Integrate with Power BI, Azure Monitor, Synapse Link, Collibra, BigID, etc. Monitoring, Auditing & Compliance Set up dashboards for audit logs, compliance reporting, metadata coverage. Oversee data lifecycle management across its phases. Support internal and external audit readiness with proper documentation. Requirements 7+ years of experience in data governance and data management. Proficient in Microsoft Purview and Informatica data governance tools. Strong in metadata management, lineage mapping, classification, and security. Experience with ADF, REST APIs, Talend, dbt, and automation via Azure tools. Knowledge of GDPR, CCPA, HIPAA, SOX and related compliance needs. Skilled in bridging technical governance with business and compliance goals. Benefits Employee Benefits Culture: Open Door Policy: Encourages open communication and accessibility to management. Open Office Floor Plan: Fosters a collaborative and interactive work environment. Flexible Working Hours: Allows employees to have flexibility in their work schedules. Employee Referral Bonus: Rewards employees for referring qualified candidates. Appraisal Process Twice a Year: Provides regular performance evaluations and feedback. Inclusivity and Diversity: Hiring practices that promote diversity: Ensures a diverse and inclusive workforce. Mandatory POSH training: Promotes a safe and respectful work environment. Health Insurance and Wellness Benefits: GMC and Term Insurance: Offers medical coverage and financial protection. Health Insurance: Provides coverage for medical expenses. Disability Insurance: Offers financial support in case of disability. Child Care & Parental Leave Benefits: Company-sponsored family events: Creates opportunities for employees and their families to bond. Generous Parental Leave: Allows parents to take time off after the birth or adoption of a child. Family Medical Leave: Offers leave for employees to take care of family members' medical needs. Perks and Time-Off Benefits: Company-sponsored outings: Organizes recreational activities for employees. Gratuity: Provides a monetary benefit as a token of appreciation. Provident Fund: Helps employees save for retirement. Generous PTO: Offers more than the industry standard for paid time off. Paid sick days: Allows employees to take paid time off when they are unwell. Paid holidays: Gives employees paid time off for designated holidays. Bereavement Leave: Provides time off for employees to grieve the loss of a loved one. Professional Development Benefits: L&D with FLEX- Enterprise Learning Repository: Provides access to a learning repository for professional development. Mentorship Program: Offers guidance and support from experienced professionals. Job Training: Provides training to enhance job-related skills. Professional Certification Reimbursements: Assists employees in obtaining professional certifications.

Data Governance Data Governance Lead Data lead
KS

Data Governance Architect

Kanerika Software

15+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Title: Data Governance Architect Job Location: Hyderabad Job Description As a Data Governance Architect at Kanerika, you will play a pivotal role in shaping and executing the enterprise data governance strategy. Your responsibilities include: What You Will Do: Strategy, Framework, and Governance Operating Model Develop and maintain enterprise-wide data governance strategies, standards, and policies. Align governance practices with business goals like regulatory compliance and analytics readiness. Define roles and responsibilities within the governance operating model. Drive governance maturity assessments and lead change management initiatives. Stakeholder Alignment & Organizational Enablement Collaborate across IT, legal, business, and compliance teams to align governance priorities. Define stewardship models and create enablement, training, and communication programs. Conduct onboarding sessions and workshops to promote governance awareness. Architecture Design for Data Governance Platforms Design scalable and modular data governance architecture. Evaluate tools like Microsoft Purview, Collibra, Alation, BigID, Informatica. Ensure integration with metadata, privacy, quality, and policy systems. Microsoft Purview Solution Architecture Lead end-to-end implementation and management of Microsoft Purview. Configure RBAC, collections, metadata scanning, business glossary, and classification rules. Implement sensitivity labels, insider risk controls, retention, data map, and audit dashboards. Metadata, Lineage & Glossary Management Architect metadata repositories and ingestion workflows. Ensure end-to-end lineage (ADF Synapse Power BI). Define governance over business glossary and approval workflows. Data Classification, Access & Policy Management Define and enforce rules for data classification, access, retention, and sharing. Align with GDPR, HIPAA, CCPA, SOX regulations. Use Microsoft Purview and MIP for policy enforcement automation. Data Quality Governance Define KPIs, validation rules, and remediation workflows for enterprise data quality. Design scalable quality frameworks integrated into data pipelines. Compliance, Risk, and Audit Oversight Identify risks and define standards for compliance reporting and audits. Configure usage analytics, alerts, and dashboards for policy enforcement. Automation & Integration Automate governance processes using PowerShell, Azure Functions, Logic Apps, REST APIs. Integrate governance tools with Azure Monitor, Synapse Link, Power BI, and third-party platforms. Requirements 15+ years in data governance and management. Expertise in Microsoft Purview, Informatica, and related platforms. Experience leading end-to-end governance initiatives. Strong understanding of metadata, lineage, policy management, and compliance regulations. Hands-on skills in Azure Data Factory, REST APIs, PowerShell, and governance architecture. Familiar with Agile methodologies and stakeholder communication. Benefits Employee Benefits Culture: Open Door Policy: Encourages open communication and accessibility to management. Open Office Floor Plan: Fosters a collaborative and interactive work environment. Flexible Working Hours: Allows employees to have flexibility in their work schedules. Employee Referral Bonus: Rewards employees for referring qualified candidates. Appraisal Process Twice a Year: Provides regular performance evaluations and feedback. Inclusivity and Diversity: Hiring practices that promote diversity: Ensures a diverse and inclusive workforce. Mandatory POSH training: Promotes a safe and respectful work environment. Health Insurance and Wellness Benefits: GMC and Term Insurance: Offers medical coverage and financial protection. Health Insurance: Provides coverage for medical expenses. Disability Insurance: Offers financial support in case of disability. Child Care & Parental Leave Benefits: Company-sponsored family events: Creates opportunities for employees and their families to bond. Generous Parental Leave: Allows parents to take time off after the birth or adoption of a child. Family Medical Leave: Offers leave for employees to take care of family members' medical needs. Perks and Time-Off Benefits: Company-sponsored outings: Organizes recreational activities for employees. Gratuity: Provides a monetary benefit as a token of appreciation. Provident Fund: Helps employees save for retirement. Generous PTO: Offers more than the industry standard for paid time off. Paid sick days: Allows employees to take paid time off when they are unwell. Paid holidays: Gives employees paid time off for designated holidays. Bereavement Leave: Provides time off for employees to grieve the loss of a loved one. Professional Development Benefits: L&D with FLEX- Enterprise Learning Repository: Provides access to a learning repository for professional development. Mentorship Program: Offers guidance and support from experienced professionals. Job Training: Provides training to enhance job-related skills. Professional Certification Reimbursements: Assists employees in obtaining professional certifications.

Data Governance Data Governance Architect Data architect
AR

Senior Analyst - Controllership, Finance

Arcesium

4+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Senior Analyst Controllership, Finance Locations: Hyderabad & Bangalore Company: Arcesium Company Overview Arcesium is a global financial technology firm helping the world s most sophisticated financial institutions tackle complex, data-driven challenges. Our innovative platform, built to anticipate risks and power transformational business outcomes, continues to redefine operational excellence in the investment management industry. With a solid market foundation and strong growth trajectory, Arcesium offers an intellectually stimulating environment, where proactive ownership, collaboration, and continuous learning are core to our success. About the Role We are looking for a dynamic and detail-oriented Senior Analyst Controllership, Finance to join our growing Finance team in Hyderabad or Bangalore. This role is ideal for a qualified Chartered Accountant with strong technical acumen in accounting, taxation, regulatory compliance, and financial controls. You will be responsible for ensuring the integrity and accuracy of financial records, maintaining strong internal controls, managing key audits, and ensuring compliance with statutory and regulatory frameworks. Key Responsibilities Financial Accounting & Reporting Drive accuracy and completeness of financial statements and month-end close processes. Ensure compliance with applicable accounting standards, including Ind AS, and corporate governance requirements. Taxation & Compliance Direct Taxation: Manage TDS payments and returns, advance tax, annual income tax filings. Handle income tax assessments and departmental correspondence. Indirect Taxation: Oversee monthly GST filings and payments, annual GST returns, and GST refund applications. Respond to GST notices and regulatory queries. Other Statutory Requirements: Ensure timely filings with ROC, RBI, SEZ, STPI, and compliance with the Companies Act and corporate laws. Maintain accurate documentation for inspections and audits. Internal Controls & Process Improvement Collaborate with internal teams to assess and strengthen internal financial controls. Conduct regular process reviews and feedback sessions to implement improvements. Prepare and maintain SOPs, RCMs, and key dashboard metrics. Stakeholder & Audit Management Serve as the point of contact for all external advisors on tax and compliance matters. Coordinate and support: Statutory audits Internal audits Tax audits IFC audits Other external/regulatory audits Treasury & Payables Oversee accounts payable processes and ensure timely, error-free vendor payments. Manage treasury operations, including cash flow forecasting, banking, and forward contracts. What You ll Need Qualifications & Experience Chartered Accountant (CA) with 4 6 years of post-qualification experience. Strong technical knowledge of: Indian Accounting Standards (Ind AS) Companies Act Direct and Indirect Taxation Skills & Tools Strong analytical mindset and a problem-solving approach. Hands-on experience with Oracle ERP (preferred). Excellent communication and interpersonal skills. A proactive team player with high attention to detail. Be part of a high-performing team tackling some of the most complex financial challenges. Enjoy a culture that values intellectual curiosity, autonomy, and inclusive collaboration. Work with a firm that truly values professional development and diverse perspectives. Equal Opportunity Employer Arcesium is committed to creating an inclusive work environment. We do not discriminate on any basis and encourage candidates from all backgrounds to apply. Qualification : Chartered Accountant (CA) with 46 years of post-qualification experience.

Senior Analyst Senior analyst Controllership Finance
MS

Senior Manager, Testing Tools Lead

Msd

5+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Opening: Senior Manager, Testing Tools Lead Location: Hyderabad, India | Full-Time About the Role Join a global healthcare biopharma company in Hyderabad and be part of a 130-year legacy of success. Backed by ethical integrity and forward momentum, we are dedicated to achieving new milestones in global healthcare. Our organization thrives on digital technology and data-backed approaches, supporting a diversified portfolio of prescription medicines, vaccines, and animal health products. Help us tackle the world's greatest health threats through innovation, execution excellence, and data-driven insights! Our technology centers are crucial to supporting our business and strategy. Globally distributed, these centers focus on delivering business solutions and enabling our digital transformation journey. Each IT division is represented at these centers, and we prioritize growth, well-being, and collaboration across teams to achieve success. Role Overview The Senior Manager, Testing Tools Lead is responsible for overseeing the implementation, maintenance, and management of software testing tools within the Enterprise IT organization. This role requires technical expertise, project management skills, and strong communication abilities. You will act as the primary liaison with the central quality engineering team and drive improvements in software testing processes and tools. What You ll Do Identify and evaluate testing tools based on project needs and organizational requirements. Lead the implementation of new testing tools and integrate them with existing systems and processes. Collaborate with and mentor testers and QA engineers, providing guidance and expertise. Organize training sessions for team members to ensure proficiency with testing tools. Review current testing processes and tools, identifying areas for improvement. Ensure continuous improvement by reviewing and updating testing SOPs and best practices. Develop and implement best practices for testing methodologies and high-quality deliverables. Oversee training on tools and standards for testing. Work closely with development teams to understand testing requirements and align strategies. Ensure effective communication between testing teams and other departments for cohesive project delivery. Maintain testing tools to ensure they are up-to-date and functioning properly. Provide technical support and troubleshooting for testing tools. Establish metrics to measure the effectiveness of testing and tool performance. Prepare and present reports on testing progress, tool usage, and quality assurance outcomes. Collaborate with the COE Lead to standardize testing methodologies for SAP products and enterprise technologies. What You Need Bachelor s or Master s degree in Pharmaceutical Sciences, Biology, Chemistry, Computer Science, Engineering, or related field. 5+ years of experience in software testing with a focus on tools and automation. Proficiency in testing tools (e.g., Selenium, JIRA, QTP, LoadRunner) and scripting languages (e.g., Python, Java, JavaScript). Experience with automated testing frameworks and CI/CD pipelines. Strong project management skills with the ability to prioritize tasks and manage timelines effectively. Familiarity with agile methodologies and SDLC processes in the pharmaceutical industry. Ability to analyze complex problems and develop effective solutions. Excellent attention to detail and a proactive approach to identifying and resolving issues. Strong verbal and written communication skills to relay technical information to non-technical stakeholders. Strong interpersonal skills to lead and collaborate with diverse teams. Desired SAP Knowledge: understanding of SAP functionalities, modules, and integrations like Concur, Ariba, Fieldglass, and MDG. Experience with service virtualization techniques and always-on testing strategies. Certifications in QA, project management, or testing (e.g., ISTQB, CSM, PMP) are a plus. Join a global company that makes a difference in patients' lives and drives health innovations. Work on transformative healthcare solutions for some of the world s most challenging diseases. Be part of a constantly evolving team that thrives on collaboration and innovation. Work with a diverse group of professionals and contribute to global progress in healthcare. We are known as Merck & Co., Inc., Rahway, New Jersey, USA, in the United States and Canada, and MSD everywhere else. For over a century, we ve been inventing for life, advancing medicines and vaccines for the world s most challenging diseases. Today, we continue to lead research to deliver innovative health solutions for the prevention and treatment of diseases threatening people and animals around the world. What We Look For If you are intellectually curious and passionate about making a global impact, join us. Here, you can leverage your creativity, technical expertise, and scientific knowledge to help save and improve lives. Our team is always evolving, and we invite you to be part of this journey to bring hope to those battling the world's most challenging diseases. Qualification : Bachelors or Masters degree in Pharmaceutical Sciences, Biology, Chemistry, Computer Science, Engineering, or related field.

Senior Manager Senior manager Testing Testing Manager
MS

Manager, Regulatory Affairs - CMC

Msd

5-7 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Opening: Manager, Regulatory Affairs - CMC Location: Hyderabad, India | Full-Time About the Role The Manager, Regulatory Affairs - CMC, is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products, in accordance with global regulations and defined regulatory strategies. This role will involve preparing and reviewing the necessary information for the development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team is dedicated to advancing medical breakthroughs by facilitating communication and procedures that ensure swift, organized compliance across regulatory agencies. As part of our international network, you will play an integral role in ensuring the compliance and approval of medical products, helping to provide reliable healthcare solutions to the world. Primary Responsibilities Regulatory Responsibilities: Provide input to global product and project regulatory strategies by assessing CMC changes and identifying global regulatory requirements. Lead the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, variations, annual reports, registration renewals, and responses to health authority questions. Liaise with global CMC, Manufacturing Divisions, and external partners to ensure compliant execution of change management. Assess and communicate potential regulatory risks and propose mitigation strategies. Ensure timely delivery of all regulatory milestones for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to GRACS CMC management as needed. Technical Skills: Review scientific information to assess the technical merits and suitability of scientific rationale, ensuring clarity and support from data. Demonstrated ability to communicate issues succinctly and logically, both orally and in writing. Solid understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance. Proficient in operating electronic document-based GMP systems. Leadership Skills: Ability to generate innovative solutions to problems and effectively communicate with key stakeholders. Demonstrated flexibility in adapting to changing priorities and dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Effective leadership, communication, and interpersonal skills. Qualifications & Skills Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Minimum of 5-7 years of experience in the pharmaceutical industry, with at least 4 years of experience in managing CMC regulatory submissions for small molecules, vaccines, or biologics. Ability to travel to other CMO sites on a need basis. Join a global company that is leading the charge in medical advancements. Play a vital role in ensuring compliance and regulatory success for life-changing pharmaceutical products. Collaborate with diverse teams to drive innovation and shape the future of healthcare. We are proud to be a company that embraces diversity and fosters an inclusive environment. At our organization, the fastest breakthroughs come when diverse ideas come together. We encourage our colleagues to challenge each other s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to promoting diversity and inclusion in the workplace. What We Look For If you re passionate about regulatory affairs and ready to make a meaningful contribution to the global pharmaceutical landscape, join us. Your expertise will help shape the future of medicine and impact generations to come. Qualification : Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.

Manager Regulatory Regulatory manager Affairs manager Regulatory affairs
MS

Specialist Process Knowledge Management

Msd

5+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Opening: Process Knowledge Management Specialist Location: Hyderabad | Full-Time About the Role The Process Knowledge Management (PKM) Specialist will act as a subject matter expert for authoring and updating Emerson DeltaV PKM process templates, process recipes, and associated master data. The primary responsibility is to ensure that Process Recipes within DeltaV PKM are successfully and compliantly designed, developed, deployed, and supported to maximize business benefits, aligning with enterprise business process and technical standards. DeltaV PKM is a new capability being developed by Emerson. This role offers the opportunity to work closely with the Emerson development team, shaping the future direction of the product. Primary Responsibilities Support DeltaV PKM training, collaboration, benefit realization, and standardization while adhering to standard processes, cGMP regulations, SOPs, and global business processes. Identify and implement continuous process improvement opportunities to enhance system performance and user experience. Assist in defining and implementing an SDLC strategy that supports the flexible use of DeltaV PKM capabilities across the development spectrum. Sustain Process recipes and master data, combining knowledge of manufacturing processes with DeltaV PKM capabilities and standards. Execute appropriate change control and life-cycle actions to ensure that the DeltaV PKM system remains in a state of control and compliance. Collaborate with teams to troubleshoot and resolve user issues efficiently, ensuring quality decisions and regulatory compliance. Provide assurance on quality systems and regulatory standards, supporting development teams and their respective quality units in fostering quality decisions. Education Bachelor s Degree and at least 5+ years of relevant experience with life sciences systems or 7+ years of relevant experience in life sciences systems. Required Experience and Skills Proven track record of analytical skills, problem-solving abilities, and attention to detail. High personal integrity, credibility, and energy with the ability to work independently and in a team environment. Excellent communication and influencing skills while working with global stakeholders (North America). Strong written and verbal communication skills, with a minimum of five (5) years of experience in a production-regulated industry. Strong understanding of manufacturing principles and processes (preferably Biologics) and ability to translate manufacturing requirements into Automation/Digital Solutions. Preferred Experience and Skills Knowledge of SAP. Knowledge of Pharmaceutical Technology Transfer processes. Be part of a dynamic, innovative company shaping the future of Process Knowledge Management. Work with cutting-edge technology in a regulated industry, contributing to significant advancements in life sciences. Collaborate with a team of dedicated professionals who value integrity and quality in everything we do. Emerson is a leader in life sciences and process control technology. We are committed to developing innovative solutions that drive global success in the manufacturing of life-saving products. Our team s collective efforts help bring critical advancements to the world of healthcare. Qualification : Bachelors Degree and at least 5+ years of relevant experience with life sciences systems or 7+ years of relevant experience in life sciences systems.

Specialist Process Process specialist Management Management Specialist
IE

Manager Group Financial Crime Compliance

Iq Eq Regcom Limited

Fresher | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Description Role summary IQ EQ Group ( IQ EQ ) is committed to maintaining the highest levels of legal and ethical standards in the conduct of its business, and places the highest importance upon its reputation for compliance with all applicable laws and rules, and for honesty and integrity. The overall goal of the Group Risk & Compliance (GRC) function is to protect the Group brand and to support the successful execution of the Group s business strategy through the delivery of an integrated risk and compliance programme across the Group. GRC aims to support the Board and senior management to fulfil their statutory and regulatory obligations, by helping to ensure compliance with the laws, regulations, principles and codes established by our regulators, and more generally by supporting the effective and continuous development and operation of the Group s risk management framework. The Manager, Group Financial Crime role reflects and supports the Group s continued commitment to combatting financial crime. The role holder is responsible for working with the Senior Manager, Financial Crime Compliance (SMFCC) in a small team within the GRC function dedicated to the development and ongoing maintenance of the Group s Financial Crime Compliance and Risk Management Programmes, reflecting the importance that the Group places on Financial Crime compliance and Risk Management, and in light of the Group s continued expansion. The roleholder is responsible for supporting the SMFCC in ensuring that robust Financial Frime Compliance and Risk Management measures are in place at a Group level and for helping to ensure that employees are aware of the Group s Financial Crime prevention obligations. The roleholder reports to the SMFCC and also works closely and collaboratively with key stakeholders, including Financial Crime Officers across the Group, to drive best practice across the Group in all matters Financial Crime related. Principal responsibilities Support the FCC Function in maintaining the Group s Financial Crime ( FC ) Risk Management and Compliance Programmes in relation to the following financial crimes Money Laundering; Terrorist Financing; Proliferation Financing; Economic & Financial Sanctions; Bribery and Corruption; Fraud; and Tax evasion Undertake periodic reviews of and draft updates to the Group s FC Policies and Procedures, ensuring that they continue to reflect key regulatory requirements and industry best practices Maintain the GFCC Policy and Standards Register and ensure all documents are updated to meet deadlines set Maintain Group FCC lists including those relating to Higher Risk Countries, Approved Regulated Markets, MLROs etc. Promote the culture and practice of Financial Crime Compliance and Risk Management helping to ensure that, among other things All staff are aware of the Group s zero tolerance approach to FC and understand the role they play in combatting it; The Group is aware of the FC risks it faces; and The Group s minimum FC standards and controls are well known throughout the business and embedded in practice. Updating existing eLearning training modules and creating new ones Own the Group FC Training Calendar, ensuring new training modules are developed, updated/in place as required to meet roll out deadlines Deliver and provide ad-hoc training on key FCC related topics to staff across the Group Manage the GFCC mailbox and ensure emails are picked up timely, escalated where required and appropriately filed. Liaise with Horizon Scanning Team to identify and assess the impacts of regulatory change (negative or positive) on the Group s FC Programmes, presenting results and proposed approaches to any changes required to the SMFCC Arrange Financial Crime Network Team calls, prepare packs and follow up on actions arising Prepare internal alerts/blogs on key FC related developments Qualifications Key qualifications and behaviours we expect to see In addition to demonstrating our Group Values, the role holder will be expected to demonstrate the following: Extensive experience in a second line of defence Financial Crime role Extensive experience in drafting and updating Financial Crime related Policies and Procedures Proven experience in creating new and updating existing Financial Crime related training material. Ability to be creative, innovate and produce engaging training content Experience with Horizon Scanning and assessing regulatory change to determine the overall impact and appropriate action that should be taken Deep understanding of and ability to interpret and apply legislation and regulations Strong organizational skills and able to deliver to agreed deadlines Strong attention to detail skills when performing everyday tasks Methodical approach to working and ability to work independently with minimal support Ability to collaborate and influence challenging stakeholders effectively Hands on and collaborative approach, but with appropriate independence of mind and sound professional judgement Solution orientated approach to issue resolution, process improvement and problem solving Consistently demonstrates excellent communication and influencing skills Resilience ability to work and adapt in a fast pace and complex environment and manage multiple priorities. Cultural awareness/sensitivity, with strong emotional intelligence Pro-actively manage own development, encompassing both technical and leadership requirements to a level appropriate to role that supports the IQ-EQ Values Required Experience Education / Professional Qualification University law degree and/or relevant professional qualification Background experience Experience of working in a second line Financial Crime compliance role in a large multi-regulator Group. Company, Product, Market knowledge Ideally possess a working knowledge of both trust and company administration and investor services (fund admin) sectors. Languages Fluent in written and spoken English Computer Expertise in Microsoft Word, E...

Manager Group manager Financial Financial manager Crime
SG

Associate Director, S1 Risk & Compliance

S&p Global

5+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Role: Associate Director, S1 Risk & Compliance Grade Level (Internal): 12 Business Division: S&P Global Sustainable1 About the Team: The Sustainable1 Business Risk & Compliance team partners closely with Sustainable1 s global business units and legal teams to identify, monitor, and manage business risks, potential conflicts of interest, and regulatory obligations. The team plays a vital role in ensuring Sustainable1 operates with integrity, complies with relevant policies, and proactively addresses emerging risks. Responsibilities & Impact: As an Associate Director within the Business Risk & Compliance team, you will help shape and enhance Sustainable1 s Compliance program by driving critical initiatives and processes across the business. Your responsibilities will include: Key Responsibilities: Develop and maintain relevant Compliance policies and guidelines to align with regulatory expectations and industry best practices. Oversee and manage day-to-day compliance activities, ensuring adherence to internal policies and preparedness for upcoming regulations. Deliver targeted education and training to Sustainable1 employees on policies, procedures, and regulatory developments. Identify and assess potential risks to Sustainable1 s business and work with stakeholders to determine and implement mitigating actions. Monitor, track, and report on policy violations and provide regular compliance reporting to senior leadership, including the Global Head of Business Risk & Compliance. Lead and participate in compliance investigations, maintaining confidentiality and diligence throughout the process. Support Risk & Compliance Operations tasks and projects as needed. Collaborate with global counterparts to ensure consistency and best practice sharing across Sustainable1 s risk and compliance functions. Partner with Legal, Government Affairs, and Public Policy teams to support regulatory engagements and policy discussions. Continuously evaluate and improve Compliance processes and workflows to enhance efficiency and effectiveness. Additional Responsibilities: Stay up to date on regulatory developments, particularly those related to ESG and sustainability. Actively participate in relevant Risk & Compliance Committees. Collaborate with Divisional and Enterprise Compliance teams to support broader compliance initiatives as required. The Impact: This role plays a pivotal part in embedding a strong compliance culture within Sustainable1, supporting the business in managing risks effectively while meeting its regulatory obligations. Through education, monitoring, and active risk management, you will help strengthen Sustainable1 s governance framework and contribute to the division s long-term success. This position reports directly to the Global Head of Business Risk & Compliance, Sustainable1. What We re Looking For: Experience: Minimum 5+ years of Compliance experience, preferably within financial services, data & analytics, or a sustainability-related business. Education: Bachelor s degree required. ESG/Sustainability domain expertise would be a significant advantage. Key Competencies: Strong understanding of compliance processes, risk management, and regulatory frameworks. High ethical standards and unwavering integrity, with the ability to stand firm on critical compliance matters. Excellent interpersonal and collaboration skills, fostering partnerships across teams and regions. Analytical mindset with problem-solving abilities and a focus on operational efficiency. Clear and concise communication skills, with experience in delivering effective compliance training across organizational levels. Strong organizational skills, with the ability to manage multiple priorities under pressure. Global mindset ability to work effectively with diverse teams across multiple jurisdictions. Technical Skills: Proficiency in Microsoft Excel, Word, PowerPoint. Familiarity with Smartsheet is preferred. About Sustainable1: S&P Global Sustainable1 is S&P Global s centralized source for sustainability intelligence, delivering comprehensive sustainability data, products, and insights across global markets. Sustainable1 helps clients assess risks, uncover opportunities, and shape long-term sustainable growth strategies. With expertise spanning climate risk, energy transition, sustainable finance, and more, we provide the Essential Intelligence that empowers companies, governments, and institutions to act with confidence in a rapidly evolving sustainability landscape. Qualification : Bachelors degree required.

Associate Director Associate director Associate s Risk
J&

Manager Data Science

Johnson & Johnson Services, Inc

5+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Description Johnson & Johnson Innovative Medicine is recruiting a Data Science Solutions Manager. The primary location for this position is in India (Hyderabad/Bangalore). Innovative Medicine develops treatments that improve the health and lifestyles of people worldwide. Research and Development areas encompass Oncology, Cardiovascular, Immunology, Neuroscience, and Infectious diseases. Our ultimate goal is to help people live longer, healthier lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market from patients to practitioners and from clinics to hospitals. In this role, you will: Partner closely with members of the Innovative Medicine R&D data science organization and other business stakeholders to lead a team to implement data science solutions and business intelligence products. You will be responsible for the delivery of engaging and innovative data products, intuitive solutions, analysis ready datasets, dashboards & insights, to make data more accessible and useful As the Data Science Solutions team, we are responsible for partnering directly with stakeholders to understand business needs and deliver products & education to increase data driven insights and decision making. Responsibilities: Recruit, develop and retain talent Provide direction, mentorship, and coaching to a team of data analysts and visualization specialists, fostering an environment of collaboration, innovation, and professional growth Build and maintain relationships with key stakeholders, ensuring that data products and solutions meet their needs while also advancing organizational goals. Apply the knowledge of pharmaceutical R&D processes to develop innovative solutions and products Ability to lead the team to develop and implement high quality data products, analysis ready data sets and apply human centered design to turn data into insights Collaborate with stakeholders to gather user requirements and understand the business needs. Design wireframes taking a user-centric approach to build intuitive products and iterate quickly to land on an efficient design. Review data products with stakeholders to ensure accuracy and alignment with the desired outcomes Incorporate feedback and suggest improvements to enhance the usability and effectiveness of visualizations. Manage multiple priorities simultaneously and consistently deliver high-quality work within established timelines. Set clear expectations with stakeholders regarding deliverables and project timelines. Stay up-to-date with the latest data management and analysis techniques and industry trends. Proactively identify opportunities to leverage data visualizations for improved decision-making. Qualifications A minimum of a Bachelor s degree is required, preferably with a major data science, bioinformatics, technology with 5 years of experience working in pharmaceutical or relevant industry Requirements: Knowledge and experience with pharmaceutical R&D, clinical development and operations Prior experience in working with clinical trial data: biomarker or clinical trial operations / clinical trial feasibility data Strong proficiency in Tableau and SQL: A portfolio of previously built data visualization is mandatory for interview. Expertise in data visualization principles and best practices. Add ability to query relational databases and work with ad-hoc files. Experience working with large and complex data sets. Experience leading teams Comfortable working with stakeholders to gather user requirements and incorporate feedback. Ability to manage multiple priorities and work effectively in a fast-paced environment. Excellent communication and presentation skills. Attention to detail and ability to ensure accuracy in data visualizations. Qualification : A minimum of a Bachelors degree is required

Manager Data Data Manager Science Data Science
AI

Sr. Associate Regulatory Affairs

Amgen Inc

1-2 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms Qualification : Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Sr. Associate Sr. associate Regulatory Regulatory associate
AI

Case Management Qa Vendor Associate

Amgen Inc

3+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Join Amgen s Mission of Serving Patients At Amgen, you ll be part of something bigger driven by our shared mission to serve patients with serious illnesses. Since 1980, we ve been pioneering biotech innovations, focusing on oncology, inflammation, general medicine, and rare disease.Join us to help make a lasting impact on patients lives while transforming your career. Case Management QA Vendor Associate What You Will Do: As a Case Management QA Vendor Associate, you will play a vital role in ensuring the quality and compliance of global case intake and processing activities. You will oversee vendors, manage case quality, and ensure adherence to regulatory requirements while supporting inspections, audits, and continuous improvement initiatives. Key Responsibilities: Monitor and ensure vendors deliver high-quality Individual Case Safety Reports (ICSRs) that meet global regulatory standards. Act as the US/EU local safety office and primary FDA/EMA point of contact for safety reporting. Provide training and resources to vendors to maintain compliance and quality. Perform quality control reviews, trend analysis, and generate reports on case quality. Manage vendor case processing timelines for adverse event intake, triage, and submission. Support inspections, audits, and CAPA (Corrective and Preventive Action) activities. Assist in Periodic Aggregate Safety Reports (PASR) processes and maintain a state of inspection readiness. Collaborate with local safety offices and attend vendor management meetings. Analyze QC trends and recommend improvements. Support onboarding and offboarding of vendor staff. What We Expect of You Basic Qualifications: Bachelor s degree with 3 years of related experience, or Associate s degree with 5 years of related experience, or High school diploma/GED with 7 years of related experience Previous experience in managing teams, projects, or resource allocation Preferred Skills: Knowledge of global pharmacovigilance regulatory requirements Proficiency in safety case processing and experience with global safety databases Strong communication skills, attention to detail, and experience supporting audits/inspections Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook What You Can Expect from Us Amgen is committed to supporting your professional growth and well-being with a collaborative, science-driven culture and a competitive Total Rewards Plan aligned with industry standards. Equal Opportunity Amgen is an Equal Opportunity Employer and embraces diversity. We provide reasonable accommodations for individuals with disabilities throughout the application process.

Management Case management Qa Management Qa QA Management
AI

Sr Validation Engineer

Amgen Inc

4-12 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Let s do this. Let s change the world. In this vital role you will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes in tools like Veeva Study Startup. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications. Defining the scope, objectives, and approach of the validation process, creating detailed validation plans, and aligning them with project timelines and resources Perform Validation testing, including Installation Qualification (IQ), Operational Qualification (OQ) for new and existing SSU Systems Ensure compliance with industry standards, regulations and internal policies during all validation activities. (GxP, FDA 21 CFR Part 11) Identify, document, and track defects during the testing process. Collaborate with development teams to define validation requirements, resolve defects and validate fixes. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the Veeva Vault Management (VVM) to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and stakeholders to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and best practices. Assist in the development and continuous improvement of validation processes and procedures Stay up to date with industry trends, best practices and evolving regulatory needs We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 11. Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. Experience in defining and executing validation strategies aligned with regulatory requirements Familiarity with risk-based approaches to validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Excellent documentation and report writing skills Good-to-Have Skills: Proficiency in automation tools, data systems, and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodology Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Veeva VM certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

Sr Validation Engineer Sr engineer Validation engineer
NO

Sr. Ecompliance Specialist

Novartis

5-10 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Summary The Senior eCompliance Specialist is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures. Sr. eCompliance Specialist provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations, etc.. Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects About the Role Key Responsibilities: • Quality oversight of Project and operational activities of GxP systems (e.g.: changes, Periodic Reviews, deviations, etc.) Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. • Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. • Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. • Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support. • Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented. • Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions. • Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System. • Perform supplier qualification assessment activities • Provides audit support as assigned and in case of CAPAs, provides the required Quality support Essential Requirements: • GXP relevant computerized systems are developed, implemented and maintained according to the Novartis requirements. • On time review and approval of changes, deviations & periodic review reports for the GxP computerized systems. • Documentation supporting eCompliance and CSV requirements is in place, maintained up-to-date and can be presented during audits and inspections without delays and issues • Gaps in eCompliance and CSV activities are proactively identified, escalated and the development of mitigation plans supported. • Client/stakeholder satisfaction and corresponding feedback Desirable Requirements: • 5-10 years of overall experience, and a minimum 4 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance • Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.) • Good experience in the development, implementation and lifecycle management of computerized systems in regulated environments • Experienced in the operational management of GxP solutions including its related technologies to support the operation • Experience in GxP supplier qualification activities • Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) • Experienced in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space • Successful cross-divisional/functional work with complex international teams • Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude • Ability to effectively interact and present to Management • Ability to influence without hierarchical authority and build trusted partnerships • Self-starter with experience in initiating and delivering projects and processes • Excellent communication, negotiation, facilitation, and interpersonal skills Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Sr. Specialist Full-Time ECompliance Compliance Management
NO

Clinical Trial Supply Manager

Novartis

3-4 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Summary We are Novartis. Join us and help us reimagine medicine. • Novartis mission: At Novartis, we reimagine medicines to improve and extend people’s lives.• Global Clinical Supply Vision: To become an intelligent, agile organization to deliver more products to more patients more efficiently through empowered and highly capable Global Clinical Supply teams. • Clinical Trial Supply Manager Vision: Be a trusted business partner by designing & delivering clinical supplies to serve our patients with excellenceAbout the RoleHSEMajor accountabilities: • CTSM will be responsible for study supply leadership to ensure timely planning and execution of supply strategy for continued supply of clinical finished goods (supply drugs) to patients. • Study managers provides inputs in clinical study protocol, understand study design and are responsible for optimal clinical trial supply strategy in terms of packaging design and pro-active planning following a risk-based approach • Represent Global Clinical Supply as a single point of contact (SPOC) at trial level for the integrated Clinical Trial team (iCTT).·Accountability and leadership • Self awareness Open to seek and receive feedback Having Right attitude·Operational & Project excellence • Proactive in study planning and assigned portfolio • Ensures to have robust risk management (identification and mitigation of risks) and various scenarios to support decision-making process • Able to navigate through current processes and procedures , while focusing on continuous improvement • Setting priorities and holding self and others accountable to meet commitments. ·Stakeholder management & Interpersonal skills • Able to engage, influence, align and lead internal and external business partners • Ability to work well with diverse groups of people, handle conflict & challenging situations effectively and build formal and informal relationships·Communication Skills & Business mindset • Able to communicate effectively with different audiences • Ability to consider business necessities and financial indicators when taking decisions and managing budgets. ·Managing Change • Ability to effective rebound from set-backs and adversity when facing difficult situations • Ability to adopt to different situations and to operate effectively during times of uncertainty.Minimum Requirements:Work Experience: • Functional Breadth. • Managing Crises. • People Challenges. • Collaborating across boundaries. • Operations Management and Execution. • Project Management. • 3-4 years relevant experience.Skills: • Advanced Project Management. • Supply Chain Planning. • Supply-Chain Management. • Data & Digital Savviness with high learning agility • Knowledge of relevant regulations (GMP, HSE)Languages : • English.

Clinical Supply Manager Clinical Manager Clinical trial manager
ES

Consultant, Life Sciences Consulting

Epam Systems

6-12 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

We are seeking a dynamic Consultant to lead our team in implementing SAPIO Sciences LIMS and ELN solutions for our clients. This position entails designing solutions and configuring SAPIO Sciences systems to align with client requirements in lab informatics. The ideal candidate will bring a wealth of technical expertise and leadership skills to successfully deliver SAPIO LIMS and ELN projects. Responsibilities Lead SAPIO Sciences LIMS and ELN project implementations Customize and script SAPIO functionalities using Python, JavaScript, and SQL Manage integration of systems using RESTful APIs, Webhook, and web services Utilize port forwarding tools such as ngrok or Cloudflare to facilitate effective system communications Oversee database management for projects, specifically with PostgreSQL or similar technologies Implement cloud deployment strategies for SAPIO solutions using AWS, Azure, or GCP Configure and maintain Gunicorn application servers and ensure smooth operation of Flask/Django frameworks for web applications Set up and manage Nginx reverse proxy servers to optimize system performance Understand and implement lab workflows, sample accessioning, and efficient lab data management practices Ensure compliance with industry standards like GxP, FDA 21 CFR Part 11 in regulated environments Requirements 6 to 12 years of experience in Lab Informatics or related fields Strong technical expertise in SAPIO Sciences LIMS and ELN implementations Background in programming with proficiency in Python, JavaScript, and SQL Extensive experience with databases, focusing on PostgreSQL or equivalent Proficiency in cloud technologies including AWS, Azure, and GCP Excellent capability in managing API integrations and utilizing port forwarding tools Strong knowledge of reverse proxy servers (Nginx) and Python web application servers (Gunicorn) Competency in understanding and managing lab workflows and data management processes Background in working within regulated industries like Pharma, Biotech, etc Nice to have Knowledge of other LIMS/ELN platforms (LabWare, LabVantage) Certification in SAPIO Sciences or related tools Familiarity with laboratory instrument integration We offer Opportunity to work on technical challenges that may impact across geographies Vast opportunities for self-development: online university, knowledge sharing opportunities globally, learning opportunities through external certifications Opportunity to share your ideas on international platforms Sponsored Tech Talks & Hackathons Unlimited access to LinkedIn learning solutions Possibility to relocate to any EPAM office for short and long-term projects Focused individual development Benefit package: Health benefits Retirement benefits Paid time off Flexible benefits Forums to explore beyond work passion (CSR, photography, painting, sports, etc.) Qualification : 6 to 12 years of experience in Lab Informatics or related fields

Consultant Sciences Life Sciences Consulting Life sciences consulting
SG

Research Analyst

S&p Global

2+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

About the Team: S&P Global is a leading provider of Environmental, Social, and Governance (ESG) data for investors, corporates, and other stakeholders. Our ESG offerings create value by helping investors mitigate long-term risks and enabling corporations to enhance their long-term financial performance. The ESG team is responsible for collecting a broad range of ESG data from various company and governmental sources, delivering an in-depth, multi-faceted view into the resilience of companies against changes in ESG factors. The team manages one of the world s most comprehensive proprietary datasets on corporate sustainability, which is leveraged across various S&P Global divisions and products to support investors, asset managers, and corporate decision-makers. Responsibilities & Impact: Data Processing & Application: Process ESG-related financial and qualitative/quantitative data, ensuring accuracy and consistency in alignment with CSA guidance. Data Collection & Validation: Collect, standardize, and validate ESG data from a range of documents, including government and regulatory filings, corporate reports, and industry publications. ESG Research & Trends: Maintain a solid understanding of ESG concepts, research methodologies, and emerging trends. Stay updated on industry knowledge and reporting standards. Collaboration & Problem-Solving: Engage with ESG analysts to identify challenges, propose solutions, and support the team with troubleshooting issues. Process Improvement: Contribute ideas for new data collection methods and propose improvements to existing processes and product offerings related to ESG content sets. Global Collaboration: Work closely with various internal teams and stakeholders across regions, ensuring the data aligns with global interests and meets the diverse needs of S&P Global s business divisions and external clients. Data Integrity & Research Support: Utilize internal and external public research sources, such as government documents, CSR reports, stock exchanges, industry journals, and analyst reports, to collect, summarize, and synthesize meaningful ESG information. Sustainability Insights: As part of S&P s ESG team, help manage one of the world s leading sustainability indices and corporate sustainability benchmarking methodologies, driving innovation in ESG research and trends. What s in it for You: Growth & Development: Join a newly established, growing team and gain valuable insights into upcoming ESG trends. Work in a project-focused, international team with opportunities for advancement. Exposure to Best Practices: Gain hands-on experience with best-in-class ESG methodologies, working alongside like-minded professionals who are passionate about sustainability. Career Progression: Opportunities for personal and professional development, with a focus on enhancing your ESG knowledge and expanding your career within the field. What We re Looking For: Basic Qualifications & Skills: Educational Background: Bachelor s or Master s degree (or equivalent) in a related field; advanced degrees are welcomed. ESG Experience: A minimum of 2 years of professional experience in ESG data ratings, research, or corporate sustainability. Technical Skills: Proficiency in Microsoft Office (Word, Excel, PowerPoint). Familiarity with ESG data tools and platforms is a plus. Document Interpretation: Ability to interpret complex corporate documents, including articles, bylaws, prospectuses, annual reports, sustainability reports, and codes of conduct. Work Schedule Flexibility: Willingness to work in rotational shifts as required, with the ability to multitask and meet deadlines in a team environment. Skills & Qualities: Strong attention to detail and a persistent approach to work. Excellent research, analytical, and problem-solving skills. Clear written and oral communication skills, with the ability to present findings effectively. Initiative and resourcefulness, with an agile mindset to adapt to collaborative environments. Ability to manage multiple priorities simultaneously in a dynamic, fast-paced work environment. Qualification : Bachelors or Masters degree (or equivalent) in a related field; advanced degrees are welcomed.

Research Analyst Research analyst Analyst research Full-Time
PA

Senior Statistical Programmer

Parexel

Fresher | Not Disclosed | Hyderabad, Telangana, India | Full-time

Key Accountabilities: Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered in the conduct of their daily work. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supporting documents and submission documentation. Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent PAREXEL at sponsor marketing and technical meetings. Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Extensive knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Good business awareness/business development skills (including financial awareness). Knowledge and Experience: Competent in written and oral English. Excellent communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Qualification : Educated to degree level in a relevant discipline and/or equivalent work experience.

Senior Statistical Programmer Senior programmer Statistical programmer
PA

Statistical Programmer-ii (fsp)

Parexel

Fresher | Not Disclosed | Hyderabad, Telangana, India | Full-time

Key Accountabilities: Project Management: Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge and Experience: Competent in written and oral English. Good communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Qualification : Educated to degree level in a relevant discipline and/or equivalent work experience.

Statistical Programmer Statistical programmer Ii Full-Time
SA

Manager - Customer Facing Effectiveness

Sanofi

7+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job title: Manager - Customer Facing Effectiveness Location: Hyderabad About the job Sanofi has currently the best and most robust pipeline of R&D and consequent new launches of our history. As new phase of Play-To-Win strategy, funding this pipeline and new launches is key to materialize the miracles of the science to improve people lives. Thus, as we enter the next phase, modernization of Sanofi is required as per the recent announcements on DRIVE, and in this respect, we are in the beginning stages of organizing the Go-to-Market Capabilities (GTMC) team at global level. Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives The GTMC organization will help us to drive best-in-class capabilities across the board and bring value and excellence in our commercial operations. This move is a key part of the aimed modernization of Sanofi and will allow us to focus on our priorities across our products, market and pipeline through the reallocation of resources and realizing the efficiencies of removing silos that exist between our business units, avoiding the duplication and overlapping of resources, standardizing our processes and tools, operating with a One Sanofi approach to accelerate our key capabilities development, and fostering the entrepreneurial spirit by speeding up the decision making. Job Summary As a Manager Customer Facing Effectiveness within our global Go-To-Market-Capabilities (GTMC) Team, you ll design, manage, and analyze data-driven incentive plans, support localization by allocating sales targets, manage incentive simulations based on global policies, track performance using KPIs for sales effectiveness, and ensure global alignment of incentive processes within the Customer Facing Hub. Main responsibilities: Design Incentives: Design, manage, and analyze incentive plans and focus on setting data-driven sales targets. Lead customer profiling and segmentation analysis ensuring a robust analysis to define target segments that are aligned with business objectives. Lead resource allocation and call planning analysis ensuring resource allocation strategies are based on segmentation insights to maximize sales force productivity. Lead performance tracking and reporting: Lead creation of dashboards, creation and analysis of KPIs, to track and monitor sales force effectiveness and efficiency Maintain effective relationship with the end stakeholders within the allocated GBU and tasks with an end objective to develop education and communication content as per requirement. Collaborate with other Customer Facing Hub Managers to ensure right data is being tracked and reported on for core processes (segmentation, incentives, ...). Secure adherence to compliance procedures and internal/operational risk controls in accordance with all applicable standards. Use latest tools/technologies/methodologies and partner with internal teams to provide support on all sort of regular and adhoc business analytics activities like build, maintenance, and enhancements of such systems Ability to work cross-functionally, gather requirements, analyse data, and generate insights and reports that can be used by the GBU Work collaboratively with the stakeholder teams to prioritize work and deliver on time-sensitive requests. Mentor the team on day to day as well as exceptional cases/ situations Monitor progress of work and provide solution to issues and queries About you Experience: 7+ years of experience within commercial operations (preferable within the healthcare and pharmaceutical industry). Soft and Technical skills: Ability to leverage networks, to develop people, coach and give feedback, empower people.; Ability to lead change while achieving business goals and objectives, act for change, challenging continuously the status quo.; High persistency and resilience.; Strong project management and planning skills.; Ability to work collaboratively in a fast-paced environment, effectively communicating complex technical concepts to non-technical stakeholders.; Knowledge of industry-specific trends and market dynamics is a plus.; Strong numeracy, analytical skills and financial acumen. Education: Higher education in Business Administration, Finance or a similar field. Languages: Excellent knowledge of English language (spoken and written). Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. Play an instrumental part in creating best practice within our Go-to-Market Capabilities. Qualification : Higher education in Business Administration, Finance or a similar field.

Manager Customer Customer manager Full-Time Manager - Customer Facing Effectiveness

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