Regulatory Project Management Jobs in Hyderabad

Job Title: Associate Manager Export Import Documentation Location: Hyderabad Employment Type: Full-time Experience: 7-10 years (Shipping/Logistics domain) Salary: INR 10-13 LPA Notice Period: 1-2 weeks / Immediate About the Role: We are seeking a skilled Associate Manager to lead and manage our export import documentation team. The ideal candidate will ensure the smooth handling of documentation processes, foster team collaboration, and maintain high standards of customer service within the logistics/shipping back-office domain. Key Responsibilities: Manage, review, and coach the export documentation team to achieve departmental goals Monitor and follow key performance metrics to ensure success and process efficiency Streamline internal documentation processes for operational excellence Foster a team-oriented and collaborative work environment Collect essential shipment data from clients to initiate documentation processes accurately Communicate regularly with clients and vendors to verify and submit precise documentation Maintain strong knowledge of export-import terminology for accurate documentation completion Promote a customer-focused approach by establishing service standards and delivering training Monitor customer satisfaction and develop innovative solutions to meet customer needs Communicate effectively through verbal, written, and listening skills to keep stakeholders informed Required Skills & Experience: 6-7+ years of back-office experience, preferably in logistics or shipping Proven project management skills with experience handling new process migrations Strong knowledge of process metrics including productivity, accuracy, and turnaround time (TAT) Experience managing a team of 20+ members directly for over 2 years Ability to work across different time zones and coordinate processes globally Excellent people management and time management skills Educational Qualifications: Postgraduate degree / MBA preferred 8-10 years of relevant experience in the shipping domain What We Offer: Competitive salary (INR 10-13 LPA) Opportunity to lead a dynamic team in a growing organization Exposure to global logistics and export-import processes Collaborative work environment and professional growth opportunities Qualification : Postgraduate degree / MBA preferred

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.

Position: EAM Domain Expert Location: Hyderabad, India Employment Type: Full-Time, Salaried Compensation: Base Salary, Bonus, Medical Benefits About Innovapptive: At Innovapptive, we are transforming industrial operations by connecting front-line workers, back-office teams, and assets through our patented, code-free platform integrated with SAP and IBM Maximo. Our mobile-first connected worker solution digitizes maintenance, operations, and supply chain processes, empowering some of the world s largest brands including Shell, UNICEF, and Newmont Mining to improve asset uptime, productivity, safety, and workforce engagement. Backed by Tiger Global Management and Vista Equity Partners, Innovapptive is recognized as one of the most innovative tech platforms by Nasscom and is Great Place to Work (GPTW) certified for three consecutive years. Role Overview: We are seeking an experienced Maintenance and Reliability Domain Expert to join our team. You will play a key role collaborating with product management and professional services to align our Industrial SaaS offerings with the real-world needs of maintenance and reliability professionals. Your deep domain expertise will help shape product strategy, optimize workflows, and enhance the connected worker experience. Key Responsibilities: Serve as the subject matter expert on maintenance and reliability best practices, including Work Identification, Planning & Scheduling, Execution, and Closure. Collaborate with product management on feature prioritization, roadmap planning, and product enhancements. Analyze user personas maintenance professionals and technicians to deeply understand their pain points and workflow challenges. Optimize maintenance workflows to enhance technician productivity and reduce backlogs. Identify opportunities to minimize downtime via preventive and predictive maintenance strategies. Design and conceptualize user-centric solutions aligned with our mobile-first connected worker philosophy. Gather and prioritize requirements from customers and internal stakeholders into actionable product features. Develop training materials and documentation tailored to maintenance professionals. Stay abreast of emerging trends, technologies, and competitive offerings in maintenance and reliability. Champion rapid product iteration, driving efficiency, quality, and speed-to-market. Collaborate cross-functionally with engineering, design, marketing, professional services, and sales teams. Advocate for customers throughout the product lifecycle using data-driven decision making, user research, and usability studies. Thrive in a fast-paced, startup-like environment demonstrating adaptability, innovation, and results orientation. What You Bring: Required Qualifications: Bachelor s degree in a relevant field; advanced degree or certifications a plus. 8+ years of experience in industrial software focusing on maintenance and reliability processes. Strong expertise in Work Identification, Planning & Scheduling, Execution, and Closure. Excellent analytical, problem-solving, communication, and presentation skills. Ability and willingness to travel as needed. Preferred: Proven collaboration with cross-functional teams (product, engineering, professional services). Experience with mobile-first and connected worker technologies. What We Offer: Competitive compensation including stock options. Exceptional health, vision, and dental coverage for you and your family. Positive, innovative, and entrepreneurial work environment. Opportunity to work with global industry leaders. Generous vacation and paid time off. Paid maternity and paternity leave. Bi-annual performance reviews in an OKR-driven culture. Access to extensive learning & development resources. Participation in diverse interest groups and employee clubs (sports, music, Toastmasters, etc.). Innovapptive does not accept unsolicited resumes from search firms. Innovapptive is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration without regard to legally protected characteristics. Qualification : Bachelors degree in a relevant field; advanced degree or certifications a plus.

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.

Product Lead Financials Reporting Location: Hyderabad Company: Arcesium Company Overview Arcesium is a global financial technology company delivering sophisticated solutions to solve complex data-driven challenges for some of the world's most advanced financial institutions. We are committed to relentless innovation in helping our clients anticipate risks, optimize operational efficiency, and achieve transformational business outcomes. Operating at the crossroads of finance and technology, Arcesium empowers team members to take ownership, think creatively, and contribute meaningfully from day one. About the Role We are looking for a Product Lead Financials Reporting to join our Product Management Group in Hyderabad. In this role, you will lead the development and enhancement of financial reporting products used by some of the world s most sophisticated hedge funds and asset managers. You will be responsible for defining product vision and strategy, translating market needs into impactful product capabilities, and working closely with engineering and cross-functional stakeholders to build solutions that support our clients evolving regulatory, financial, and operational needs. Key Responsibilities Product Strategy & Vision Define and drive the vision, strategy, and roadmap for financial reporting products, in alignment with Arcesium s overall platform goals. Conduct market research, client interviews, and competitive analysis to identify product opportunities and trends. Build and maintain a forward-looking product roadmap grounded in user needs, technical feasibility, and business value. Execution & Delivery Collaborate with engineering teams to convert specifications into scalable, high-quality financial reporting solutions. Own feature definition, product design, and delivery through iterative releases and feedback loops. Monitor progress through test cases and validation frameworks to ensure features meet both business and technical expectations. Stakeholder Management Communicate product strategy, project plans, and progress updates with internal and external stakeholders. Collaborate with other product managers and cross-functional teams to integrate financial reporting into broader solutions. Prepare documentation such as release notes, business cases, and technical briefs. What You ll Need Experience & Expertise 6+ years of total experience with at least 2 years in product management. Deep understanding of financial reporting processes in hedge funds, asset management, or other alternative investment domains. Strong grasp of financial instruments, accounting standards, and regulatory frameworks relevant to financial reporting. Skills & Tools Advanced Excel skills and strong data analysis capability. Experience working closely with software engineers in an Agile or collaborative product development setting. Familiarity with interpreting counterparty statements and managing complex data sets. Soft Skills Excellent written and verbal communication skills. Strong critical thinking and problem-solving abilities. Confident stakeholder management and influence across technical and business teams. Detail-oriented, self-driven, and highly organized with a collaborative mindset. What Sets You Apart A healthy mix of domain expertise, strategic thinking, execution rigor, and customer empathy. Ability to thrive in a high-performance, data-driven, and fast-paced environment. Passion for delivering innovative financial technology solutions at scale. Equal Opportunity Employer Arcesium is an equal opportunity employer committed to diversity and inclusion. We welcome candidates from all backgrounds and ensure a workplace free from discrimination.

Data Architect Hyderabad Experience: 10-17 Years Job Type: Full-Time | On-site/Hybrid Location: Hyderabad, India Industry: Data Engineering / Cloud Architecture Job Overview We are looking for an experienced Data Architect with 10+ years of expertise in designing, optimizing, and managing enterprise-scale data architectures on Azure Cloud. The ideal candidate will lead efforts to enhance data pipeline performance, ensure robust data governance, and drive cost-effective cloud resource utilization. If you excel in architecting scalable, secure, and high-performing data solutions, this is your chance to join a dynamic team in Hyderabad. Key Roles & Responsibilities Design, optimize, and maintain data pipelines, ETL processes, and complex queries to maximize performance and scalability. Improve query execution plans, indexing strategies, and optimize storage in Azure SQL, Azure Synapse Analytics, and Azure Data Lake. Implement advanced data management techniques such as data partitioning, caching, and compression for efficient data processing. Monitor cloud resource consumption and implement cost-saving strategies without impacting system performance. Optimize use of Azure services including Databricks, Data Factory, Synapse Analytics, and storage accounts to balance performance and cost. Establish and enforce coding standards, design patterns, and best practices for data pipeline development and cloud infrastructure management. Define and implement data governance, security, and compliance policies aligned with organizational and regulatory requirements. Develop and oversee CI/CD pipelines using DevOps methodologies tailored to data engineering workflows. Implement monitoring, alerting, and logging solutions using Azure Monitor, Log Analytics, and Application Insights to ensure system reliability. Architect solutions for high availability and disaster recovery to maintain business continuity. Optimize Power BI data models, DAX queries, and report performance; ensure governance and data refresh strategies meet business needs. Collaborate with cross-functional teams and business stakeholders to translate requirements into scalable and actionable data insights. Required Skills & Qualifications 10+ years of experience in data architecture, cloud data engineering, or related roles. Deep expertise in Azure Cloud data services: Azure SQL, Synapse Analytics, Data Lake, Databricks, Data Factory. Strong background in ETL pipeline optimization, query tuning, and storage management. Proven experience with data governance, security frameworks, and compliance standards. Familiarity with DevOps principles, especially CI/CD for data workflows. Expertise in monitoring tools like Azure Monitor, Log Analytics, and Application Insights. Hands-on experience optimizing Power BI solutions, including data modeling and report design. Excellent communication and stakeholder management skills. Work on large-scale, cutting-edge data projects impacting enterprise business decisions. Collaborate with a passionate, skilled team in a fast-paced, innovative environment. Competitive salary and benefits package. Opportunity to shape the future of data architecture within a leading organization. Apply Today If you are an expert Data Architect ready to take your career to the next level with advanced Azure data technologies, apply now and join our Hyderabad team!

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.

Job Summary The Corporate Accounting Trainer is responsible for designing, developing, and delivering high-impact technical training programs focused on accounting principles, financial systems, and regulatory compliance. This role combines deep accounting expertise with strong instructional capabilities to enhance the technical competencies of our financial teams. Key Responsibilities Training Design & Development Design and develop comprehensive technical training curricula for accounting processes, financial systems, and compliance requirements Create engaging training materials including presentations, handouts, and practical exercises that effectively convey complex accounting concepts Maintain and update training content to reflect current accounting standards, regulatory changes, and internal process updates Develop assessment tools to evaluate learning effectiveness and knowledge retention Training Delivery Conduct in-person and virtual training sessions on accounting principles, financial software applications, and internal controls Deliver new hire orientation programs covering essential accounting procedures and systems Facilitate advanced technical workshops for experienced staff on complex accounting topics Adapt training delivery methods to accommodate different learning styles and experience levels Program Management Assess training needs through consultation with department heads and analysis of performance metrics Track and report on training completion rates, assessment results, and program effectiveness Manage training schedules and coordinate with departments to ensure maximum participation Evaluate and recommend improvements to training programs based on participant feedback and observed results Maintain detailed records of training activities, attendance, and certifications Technical Support Provide post-training support to reinforce learning and address specific questions Create quick reference guides and job aids for common accounting procedures Collaborate with subject matter experts to ensure technical accuracy of training content Stay current with accounting standards, best practices, and industry trends Qualifications Required Experience Bachelor's degree in Accounting, Finance, or related field Professional accounting qualification (CPA preferred) Minimum 5 years of accounting experience in a corporate environment Demonstrated experience in training delivery or adult education Advanced knowledge of accounting principles, standards, and regulations Proficiency in financial software and Microsoft Office applications Key competencies for position and level Technical Expertise: Strong foundation in accounting principles and practices Communication: Clear and effective verbal and written communication Leadership: Ability to guide and influence learning outcomes Innovation: Creative approach to training design and delivery Analysis: Strong analytical and problem-solving abilities Adaptability: Flexible response to changing needs and environments Key behaviours we expect to see In addition to demonstrating our Group Values (Authentic, Bold, and Collaborative), the role holder will be expected to demonstrate the following: Excellent presentation and communication skills Strong instructional design and facilitation abilities Ability to explain complex concepts in clear, understandable terms Superior organizational and project management capabilities Proven ability to engage and motivate adult learners Qualification : Bachelor's degree in Accounting, Finance, or related field

Job Description Responsibilities Drawing on your existing experience in Corporate, Company or Fiscal law you will be responsible for coordinating the day to day administrative and legal formalities for our varied and complex client portfolios. This will include real estate and corporate entities including trusts and companies. You have to be highly organized, reliable, work independently, pay close attention to details and know your subject matter as you will be dealing with queries relating to legal matters of holding companies. You will build strong customer relationships with existing and new clients, banks and other external parties, gaining insight into their needs and delivering customer-centric solutions also ensuring we meet our legal and contractual requirements. Compliance and regulations has never been more complex; you ll need to ensure we comply and meet our KYC obligations by preparing, monitoring and maintaining robust client files, safeguarding from potential risks. You are able to support young team members and reviewing their work. You will lead board and shareholders meetings, reviewing related minutes, agreements and documentation. We are never complacent and always encourage our people to look for ways to improve our business; here everyone s opinion counts and we will value your contribution. Your long-term career goals are important to us too. We want to make sure we re providing the support and opportunities you need to achieve your dreams so we can build a successful future, together. Qualifications Qualifications You have a Bachelor or Masters degree in Corporate / Company Law and CS Semi qualified. 3 to 5years of legal experience inthe financialsector. Your communication skills are excellent, both verbal and in writing inEnglish; You have strong analytical skills and mature judgment; You re Client focused, Organized and Accurate Company description IQ-EQ is a leading Investor Services group which combines global expertise with an unwavering focus on client service delivery. We support fund managers, global companies, family offices and private clients operating worldwide. Qualification : You have a Bachelor or Masters degree in Corporate / Company Law and CS Semi qualified.

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...

Job Title: Senior Product Manager/Strategy Company: Oracle Location: Hyderabad Position Summary Oracle is seeking a Product Manager for its Oracle Insurance Policy Administration (OIPA) product within the Life & Annuities insurance space. OIPA is a leader in the market for life insurance policy administration, offering scalable and flexible solutions for life insurers. As a Product Manager, you will lead the full lifecycle of these products, from ideation through to market launch, working closely with cross-functional teams to deliver customer-centric solutions. Key Responsibilities Product Leadership: Own the end-to-end product lifecycle for Life & Annuities insurance solutions. Define and execute the product strategy, roadmap, and vision, aligning with organizational goals and market needs. Collaborate with cross-functional teams (engineering, design, marketing, sales, operations) to deliver innovative, scalable solutions. Industry Expertise: Possess deep knowledge of Life & Annuities insurance products (term life, whole life, universal life, annuities, riders). Lead the design of product templates and configurations for streamlined implementation. Stay updated on regulatory, market, and technological trends to anticipate changes and opportunities. Innovation with GenAI: Explore and implement Generative AI-driven solutions to enhance product personalization, underwriting, customer service, and claims management. Work closely with data science and engineering teams to develop AI-enabled tools and bring innovative solutions to market. Stakeholder Communication: Present complex ideas and strategies to stakeholders, clients, and executive leadership in a compelling manner. Develop persuasive product documentation, including business cases, product requirements, and technical specifications. Represent Oracle at industry events, conferences, and client meetings. Implementation Expertise: Leverage experience in implementing Life & Annuities insurance products across various platforms. Work with delivery teams to ensure seamless product launches and customizations. Additional Responsibilities: Gather and document business requirements for new enhancements. Collaborate with product teams to develop user stories, UI mock-ups, and solicit user feedback. Work with sales and marketing teams to develop product collateral and maximize product adoption. Conduct presentations and training sessions to internal stakeholders, customers, and partners. Ideal Candidate Qualifications/Skills Education: Bachelor s or Master s degree in Commerce, Business, or Computer Science from a reputed college/university. Experience: At least 8 years of relevant experience with a minimum of 6 years in Life & Annuities insurance. Industry Expertise: Strong experience in designing or implementing Life & Annuities insurance products. Solutioning Skills: Proven track record of delivering client-focused solutions and managing implementation plans. Project Management: Ability to manage multiple projects, deadlines, and priorities in a fast-paced environment. Collaboration: Strong organizational skills and the ability to work effectively across cross-functional teams. Self-Starter: Proactive, results-driven with a focus on continuous improvement and staying updated with emerging market trends and technologies. Certifications: Any certifications in the Life Insurance domain are a plus. Preferred Skills Experience with Generative AI applications in insurance. Strong leadership and communication skills to engage internal and external stakeholders. Prior experience with insurance policy administration systems. Qualification : Bachelors or Masters degree in Commerce, Business, or Computer Science from a reputed college/university.

Job Title: Product Manager - Life & Annuities Insurance Solutions Company: Oracle Location: Hyderabad Position Summary Oracle is looking for a Product Manager to join the Oracle Insurance Policy Administration (OIPA) team. OIPA is a market leader in Life Insurance Policy Administration, helping insurers streamline their operations on a single platform, running on the secure, scalable Oracle Cloud Infrastructure. This role involves owning the entire product lifecycle for Life & Annuities insurance solutions and driving the product strategy, innovation, and customer experience. Key Responsibilities Product Leadership: Own the end-to-end product lifecycle, from ideation to market launch, for Life & Annuities insurance solutions. Define and execute the product strategy, roadmap, and vision, aligning with organizational goals and market needs. Collaborate with cross-functional teams (engineering, design, marketing, sales, operations) to deliver customer-centric, scalable solutions. Industry Expertise: Bring deep knowledge of Life & Annuities insurance products (term life, whole life, universal life, annuities, and riders). Lead the design and conceptualization of product templates and configurations to streamline implementation. Stay updated on regulatory, market, and technological trends to anticipate changes and opportunities. Innovation with GenAI: Implement Generative AI-driven solutions to enhance product personalization, underwriting, customer service, and claims management. Collaborate with data science and engineering teams to develop AI-enabled tools and deliver innovative solutions. Stakeholder Communication: Present complex ideas and strategies to stakeholders, clients, and leadership in a clear, compelling, and professional manner. Develop persuasive documentation, including business cases, product requirements, and technical specifications. Act as a thought leader, representing Oracle at industry events, conferences, and client meetings. Implementation Expertise: Leverage experience in implementing Life & Annuities insurance products across multiple platforms. Partner with delivery teams to ensure seamless product launches and customizations, meeting client-specific requirements. Additional Responsibilities: Gather and document business requirements for new enhancements and product developments. Collaborate with the product team to develop user stories, UI mock-ups, and analyze user feedback. Work with sales and marketing to develop high-quality product collateral and maximize product adoption. Conduct presentations and training sessions for internal stakeholders, customers, and partners. Ideal Candidate Qualifications/Skills Education: Bachelor s or Master s degree in Commerce, Business, or Computer Science from a reputable college/university. Experience: 8+ years of experience in Life & Annuities insurance, with at least 6 years in life insurance. Solutioning Skills: Strong history of delivering extraordinary solutions to clients and managing implementation plans. Project Management: Ability to manage multiple projects, deadlines, and priorities in a fast-paced environment. Collaboration: Excellent collaboration and organizational skills; ability to work effectively across diverse teams. Self-Starter: Proactive, results-oriented, with a can-do attitude and focus on continuous improvement. Insurance Expertise: Prior implementation or product development experience in insurance policy administration systems. Certifications: Any certifications in the life insurance domain are a plus. Qualification : Bachelors or Masters degree in Commerce, Business, or Computer Science from a reputable college/university.

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.

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

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.

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

If you re looking for a career where you can make a real impression, join HSBC and discover how valued you ll be. HSBC is one of the largest banking and financial services organisations in the world, with operations in 62 countries and territories. We aim to be where the growth is, enabling businesses to thrive and economies to prosper, and, ultimately, helping people to fulfil their hopes and realise their ambitions. We are currently seeking an experienced professional to join our team in the role of Assistant Vice President HBEU Reporting Operations Principal responsibilities Ensuring consistency among various reporting deliverables in integrated reporting including but not limited to financial statement, capital adequacy & liquidity coverage. Manage Delivery of high quality regulatory outputs including regulatory returns, disclosures and internal MI Presenting to the stakeholders and seeking sign off s before regulatory submission or submission for group. Support the production of existing and designing new integrated reporting information requirements and disclosures (ensuring best practice and compliance with listing requirements and regulatory standards). Proficiency in handling the audit & review queries from internal audit, external audit & regulators supervisory controls (S166). Ensuring that all assurance checks are performed ahead of finalization of numbers and preparation of assurance packs for sign off meetings including variance analysis and review of controls checklist. To be well versed with regulatory interpretation & definition prescribed in various regulation including ECB guidelines, PRA regulation, Applied policies & accounting standards. In-depth knowledge of at least two verticals in either of Financial reporting / Regulatory Reporting / Liquidity reporting. Work with Finance Change delivery, Global Regulatory policy and Remediation programs on upcoming Regulatory changes, business requirements and system enhancements to ensure the solutions delivered are fit for purpose and meets the desired objectives. Active participation in User Acceptance Testing (UAT) for every change/release to drive consistency and efficiency and also highlighting the issues and taking it for remediation. Requirements A qualified professional (preferably CA or ICWA or MBA or CFA) with overall post qualification experience of 8+ years. Sound knowledge of the Financial/Banking Services industry, products and systems. Sound understanding of IFRS, experience in analysis of financial statements, IFRS and audit/compliance Ability to work under pressure, report under tight deadlines and deal effectively with issues as they arise. Prior experience in Regulatory Reporting, Liquidity or Financial Reporting function will be an advantage. Preferably having knowledge and experience in Basel III/CRDIV and PRA regulatory rules; AOP & Stress Testing reporting. The role holder will also continually reassess the operational risks associated with the role and inherent in the business, taking account of changing economic or market conditions, legal and regulatory requirements, operating procedures and practices, management restructurings, and the impact of new technology. Knowledge of Python, R, Xceptor or any upcoming technology used within Finance for automation would be preferred. Qualification : A qualified professional (preferably CA or ICWA or MBA or CFA) with overall post qualification experience of 8+ years.

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.

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.

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