Regulatory Affairs CMC Expert Jobs in Hyderabad

Oracle Database Administrator Location: Hyderabad, IN Employment Type: Full-Time Role Overview We are looking for a skilled Oracle Database Administrator (DBA) to join our IT team. The ideal candidate will be responsible for maintaining the performance, integrity, and security of our Oracle databases to ensure continuous availability and reliability. This role involves proactive monitoring, troubleshooting, and collaboration with various teams to support business-critical applications. Key Responsibilities Database Management: Install, configure, upgrade, and patch Oracle database software and related tools. Create and manage database instances, storage, schemas, and database objects. Implement and maintain robust backup and recovery strategies using tools like RMAN. Performance Optimization: Monitor and optimize database performance through tuning, indexing, and query optimization. Analyze and resolve bottlenecks and performance issues. Manage clustering, replication, Data Guard, and load balancing configurations to ensure high availability. Troubleshooting and Support: Provide technical support and timely resolution of database issues. Collaborate with developers and IT teams to resolve complex problems affecting database performance or availability. Security and Compliance: Implement database security policies including access controls, encryption, and auditing. Ensure compliance with organizational and industry security standards through regular audits and assessments. Data Integrity and Management: Maintain data integrity and consistency through sound database design and maintenance. Oversee data archiving, purging, and retention policies to meet business and regulatory needs. Support data migration and integration initiatives. Documentation and Reporting: Document database configurations, maintenance procedures, and policies. Prepare reports on database performance, capacity, incidents, and trends. Capacity Planning: Monitor and analyze database capacity and utilization to plan for future growth. Develop capacity planning strategies and execute upgrades as required. Automation and Scripting: Develop and maintain scripts to automate routine database maintenance, backups, and monitoring tasks. Implement automation tools to improve operational efficiency. Qualifications Education: Bachelor s degree in Computer Science, Information Technology, or related field, or equivalent experience. Experience: Proven experience as an Oracle Database Administrator or similar role. Hands-on expertise with Oracle Database, RMAN, ASM, Data Guard, and related technologies. Skills: Strong knowledge of database architecture, normalization, indexing, and transaction management. Proficiency in SQL and PL/SQL programming. Experience in performance tuning, query optimization, and troubleshooting. Familiarity with database security best practices and tools. Competent with database monitoring and management tools. Excellent problem-solving, analytical, and communication skills. Certifications: Oracle Certified Professional (OCP) or Oracle Certified Expert (OCE) certifications are highly desirable. Qualification : Bachelors degree in Computer Science, Information Technology, or related field, or equivalent experience.

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.

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.

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 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.

About KPMG in India KPMG India is a leading professional services firm, affiliated with KPMG International Limited. Established in August 1993, we combine global expertise with a deep understanding of local regulations, laws, markets, and competition. With offices across major cities in India including Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Jaipur, Hyderabad, Kochi, Kolkata, Mumbai, Noida, Pune, Vadodara, and Vijayawada we offer services to national and international clients across various sectors. At KPMG, we deliver rapid, performance-based, industry-focused, and technology-driven solutions that reflect our vast experience in both global and Indian business environments. Role Overview As part of our effort to support clients in reducing their compliance burden, we seek a talented individual to contribute to our team by assisting in various compliance and regulatory activities. This role focuses on helping clients streamline processes and reduce administrative overhead across different sectors. Equal Employment Opportunity (EEO) Information KPMG India is committed to providing equal employment opportunities to all applicants and employees, regardless of color, caste, religion, age, gender, national origin, citizenship, sexual orientation, gender identity or expression, disability, or any other legally protected status. We value diversity and encourage you to voluntarily share demographic details to support our diversity initiatives. Providing this information is entirely optional and will not affect your application. Qualifications: Educational Requirements: Post Graduate in Commerce/Economics or an MBA. Qualification : Post Graduate in Commerce/Economics or an MBA.

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 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...

Compliance Program Manager At Coinbase, our mission is to increase economic freedom in the world. It s a massive, ambitious opportunity that demands the best of us, every day, as we build the emerging onchain platform and with it, the future global financial system. To achieve our mission, we re seeking a very specific candidate. We want someone who is passionate about our mission and who believes in the power of crypto and blockchain technology to update the financial system. We want someone who is eager to leave their mark on the world, who relishes the pressure and privilege of working with high caliber colleagues, and who actively seeks feedback to keep leveling up. We want someone who will run towards, not away from, solving the company s hardest problems. Ourwork cultureis intense and isn t for everyone. But if you want to build the future alongside others who excel in their disciplines and expect the same from you, there s no better place to be. We are seeking an experienced Compliance Program Manager to oversee the execution of high-priority regulatory compliance Programs within the company s Transaction Monitoring (TMS) and Screening functions. This role involves leading strategic, multi-regional Programs to ensure compliance with global AML regulatory bodies. The Program Manager will ensure the integration of regulatory requirements into policies, overseeing their documentation and practical implementation across the business. Additionally, the role will focus on 1) launching new TMS and Screening programs into new products 2) driving automation and process efficiencies and 3) resolve internal audit findings and ensure all operational processes related to TMS and Screening are aligned with compliance standards. What you ll be doing (ie. job duties): Lead cross-functional teams to deliver large-scale, global projects ensuring that all TMS and Screening Program objectives are met on time and within scope. Work across Technology, Operations, Compliance and Product teams to continually refine and improve TMS and Screening processes, ensuring they remain compliant with regulatory requirements whilst ensuring a best in class customer experience. Lead the translation of Compliance requirements and policies into operations processes and procedures for the TMS and Screening function. Ensure requirements for new TMS and Screening programs across new businesses or products are launched on time and satisfy compliance and business requirements. Develop and maintain a detailed Program plan, setting milestones, managing resources, and identifying key deliverables to ensure successful outcomes. Engage with key stakeholders (legal, risk, compliance, operations) to ensure ongoing communication and alignment of goals. Establish robust mechanisms and feedback loops to gather operations / investigator feedback on TMS and Screening processes, to improve upstream Compliance and Product controls. Lead the development of dashboards and KPIs to monitor the success of the compliance Program and track adherence to global regulatory requirements. Utilize an in-depth understanding of metrics, reporting, capacity planning and financials to make informed data-driven decisions. What we look for in you (ie. job requirements): Motivated by Coinbase s mission 5+ years of proven transaction monitoring / AML experience in financial services or technology organizations. 3+ years of program management experience across global and cross functional teams. Working knowledge of laws, regulations, and risk management practices for financial services. Hands-on involvement in defining metrics that tie back to how we measure success. Proficient in PowerPoint/Google Slides and Excel/Google Sheets. A BA/BS degree in business, finance, and other related fields. Nice to haves: Advanced degree in business, finance, and other related fields. Experience with and/or keen interest in cryptocurrency. Experience working across multiple AML systems and programs simultaneously (e.g., experience in combinations of KYC, AML, and Sanctions). Professional certifications (e.g. CRCM, CAMS, CIA, CISA, and CICA). Deep understanding of Google apps, JIRA, Salesforce Service Cloud. Qualification : A BA/BS degree in business, finance, and other related fields.

KYC EDD Analyst II At Coinbase, our mission is to increase economic freedom in the world. It s a massive, ambitious opportunity that demands the best of us, every day, as we build the emerging onchain platform and with it, the future global financial system. To achieve our mission, we re seeking a very specific candidate. We want someone who is passionate about our mission and who believes in the power of crypto and blockchain technology to update the financial system. We want someone who is eager to leave their mark on the world, who relishes the pressure and privilege of working with high caliber colleagues, and who actively seeks feedback to keep leveling up. We want someone who will run towards, not away from, solving the company s hardest problems. Ourwork cultureis intense and isn t for everyone. But if you want to build the future alongside others who excel in their disciplines and expect the same from you, there s no better place to be. This role is for the KYC EDD Analyst II as part of the operations function in the Compliance team, reporting to the Team Manager Compliance operations. In this role, Compliance EDD Analyst - II will be responsible to manage the speciality case work streams. In this role, candidates will be expected to work on the high net worth individual cases and deal with executive escalations for such customers. Through the investigation into the KYC documents, candidates will be expected to safeguard the customer experience by satisfying the compliance regulatory requirements. Additionally, candidates will have certain metrics to achieve as a part of business operations. Onboarding retail customers with adherence to Coinbase s AML program, BSA/AML, KYC, and EDD policies, procedures and standards appropriate for each jurisdiction in which Coinbase operates. You will serve as the subject matter expert and escalation point within the KYC EDD team and the broader AML team and manage client onboarding and remediations. To be successful in this role, you will need to have a proven track record of subject matter expertise for an onboarding KYC program, have an enthusiastic and positive attitude, have a strong knowledge of KYC best practices, and a proven ability of taking innovative approaches to solving complex regulatory challenges. If you're ready to take on a challenge that will make a difference in the world, we want you on our team. Apply now and be a part of something truly transformative! What you ll be doing (ie. job duties): Lead and execute comprehensive EDD on High-risk customers, transactions, and high-net worth individuals, ensuring thorough risk assessment. Review, analyze, and validate KYC information to ensure it aligns with internal policies, regulatory requirements, and quality standards. Identify, assess, and escalate suspicious activities with precision, providing clear and actionable recommendations. Complete review in a timely and efficient manner, ensuring application of risk based approach helping mitigating any AML risk and at the same time ensuring a good customer experience Make recommendations on process improvements to increase efficiency and accuracy Provide mentorship and guidance to junior analysts, fostering a culture of excellence and continuous improvement. Collaborate with internal support teams across Data Analytics, Escalations teams, Financial Crime Compliance, and L&D to help launch or improve existing processes and workflow Utilize an in-depth understanding of metrics to drive data-driven recommendations Maintain awareness of regulatory updates and incorporate process and procedural changes in the due diligence review process Identify process gaps and work with stakeholders within CX and financial crime to improve the process. Provide regular insights, recommendations and feedback to Client Service Management Continuously add value through effective impact analysis, prioritization, root cause analysis and efficient execution of initiatives. Tackle routine problems, largely through precedent and referral to general guidelines What we look for in you (ie. job requirements): Years of experience: minimum 2 years of compliance experience (Enhanced Due Diligence [EDD]) Minimum Bachelor s degree or equivalent Knowledge of on-boarding checks, entity types and AML/KYC laws, guidelines (e.g. BSA, OFAC, FinCEN guidance), and rules for financial products & services Strong written/verbal communication, critical thinking, and problem-solving skills Experience working with Google Sheet, Google Doc, Excel, Word Flexible and adaptable to the evolving needs of a high-growth and fast paced organization environment Multi-tasking ability, team-oriented, and a self-starter Ability to work with limited direction from management when situations occur Intermediate to advanced level in PowerPoint/Google Slides and Excel/Google Sheets Ready to support in 24*7 environment Organized with a high level of attention to detail Work from the office 100%, no hybrid or work from home. Nice to haves: Knowledge of the cryptocurrency industry. Professional certifications (e.g. CRCM, CAMS, CIA, CISA, and CICA). Deep understanding of Google apps, JIRA, Salesforce Service Cloud.

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 re part of something bigger our shared mission to serve patients with serious illnesses drives everything we do. Since 1980, we ve been pioneers in the biotech industry, focusing on Oncology, Inflammation, General Medicine, and Rare Diseases, helping millions of patients live longer, fuller lives. Amgen remains on the cutting edge of innovation, combining biology and technology with human genetic data to push beyond what s possible today. Specialist IS Engineer What You ll Do As a Specialist IS Engineer, you will develop and implement the next generation of pharmacovigilance platforms while supporting existing technologies. This includes designing, developing, and deploying complex software solutions while mentoring junior developers. You ll collaborate with cross-functional teams to deliver high-quality, scalable solutions that ensure system reliability and innovation in safety systems. Key Responsibilities Design, develop, and deploy solutions for pharmacovigilance systems to enhance adverse event intake and distribution. Ensure technical implementation aligns with GxP validation processes and IS Change Control standards. Collaborate with partners to prioritize system enhancements and new functionalities for safety systems. Develop innovative solutions using Generative AI and large language models (LLMs) like OpenAI GPT for improved decision-making and efficiency. Rapidly prototype and translate concepts into working code. Drive automation and process improvements within the drug-safety ecosystem. Conduct code reviews and maintain technical documentation for architecture, design, deployment, and disaster recovery. Lead technical root cause analyses and collaborate with software vendors to resolve system-related issues. Basic Qualifications Master s Degree with 4 6 years of experience, or Bachelor s Degree with 6 8 years of experience, or Diploma with 10 12 years of experience in Computer Science, Software Development, or a related field Required Skills Must-Have: Proficiency in SQL, Databricks, and data modeling concepts Experience in Python or JavaScript and reporting tools like Power BI or Tableau Familiarity with PV terminologies and regulatory compliance Hands-on experience with SDLC, ETL tools (Informatica, Databricks), and API integrations (MuleSoft) Strong problem-solving skills, collaborative mindset, and effective communication Knowledge of ITIL processes and GxP validation Nice-to-Have: Experience with COTS Pharmacovigilance Platforms (e.g., Argus) Cloud experience with AWS or Azure Knowledge of AI, Machine Learning (ML), Natural Language Processing (NLP) Professional certifications such as SAFe Agile Software Engineer or SAFe for Teams Soft Skills Strong verbal and written communication skills Analytical and problem-solving mindset Ability to collaborate with global, virtual teams Initiative-driven with an ownership mindset Adaptability and resilience in ambiguous situations What You Can Expect Amgen offers a collaborative, science-driven culture and comprehensive benefits, including competitive salaries, professional growth support, and a focus on your well-being. Shift Information: This role may require working late shifts, with potential for evening or night schedules based on business needs. Apply now to make a real difference in the lives of patients while transforming your career at careers.amgen.com. Equal Opportunity Employer: Amgen is committed to creating a diverse and inclusive environment. We provide reasonable accommodations to individuals with disabilities.

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

We are currently seeking an experienced professional to join our team in the role of Consultant Specialist. Role: Consultant Specialist Key Responsibilities: Requirement Analysis: Analyze and finalize business requirements, estimate effort and schedule, and lead sprint planning sessions with well-defined user stories and story points. Impact Analysis: Identify dependencies and blockers, prepare remediation plans, and collaborate with teams across business lines to address impact and required changes. Design: Develop and review technical design to align with department and organizational objectives. Address issues in advance with relevant teams. Coding: Develop and review code based on specifications, adhering to defined coding standards and best practices. Reviews: Conduct design, code, test plan, and test result reviews. Ensure quality of deliverables, address defects, and ensure adherence to outlined processes and practices. Testing: Engage with source and downstream interface teams to deliver well-structured, maintainable, and fully tested systems within time and budget. Implementation: Conduct release planning sessions at the end of each sprint, prepare and review the plan for implementation, and ensure smooth execution of releases. Support: Provide post-implementation support and participate in 24x7 on-call duties, taking ownership of fixing production events. Audits: Ensure compliance with SOX and other audit requirements, and conduct sprint reviews and retrospectives. Maintain documentation for team processes, best practices, and software run books. Collaboration & Adaptability: Work with a globally distributed cross-functional team to build customer-centric products. Embrace changing requirements to provide competitive advantages for our customers. Requirements: To be successful in this role, you should meet the following criteria: Experience: 8-10 years of IT experience, including extensive hands-on experience with React JS, JavaScript, CSS, HTML, Python, and Flask Web Framework. Full Stack Expertise: Proficiency as a Full Stack Engineer, with hands-on experience in React JS/JavaScript and bridging the gap between frontend and backend development. Technical Skills: Strong experience with Oracle/SQL, architecture and design, and end-to-end coding and application development. Stakeholder Management: Experience managing stakeholders across business, architecture, infrastructure, and IT. Production Support: Prior experience in 24x7 on-call support and ensuring continuous operation and issue resolution in production environments. Agile & DevOps: Familiarity with Agile methodologies (Scrum, Kanban, Sprints) and DevOps practices. Regulatory & Compliance: Knowledge of regulatory issues and internal controls, ensuring adherence to compliance policies. Documentation & Delivery: Ability to prepare design documents, analyze requirements, and deliver solutions on schedule while adhering to engineering and quality standards. At HSBC, you'll be part of a dynamic environment that offers continuous professional development, flexible working options, and a collaborative culture. Join us to be part of a global organization where your contributions will make an impact.