Senior Associate, Data Management – Amgen | Hyderabad, India
Category: Regulatory
Work Model: On-Site
Job ID: R-230494
Posted: November 17, 2025
Job Overview
Amgen is seeking a Senior Associate, Data Management to support regulatory data operations within the Global Regulatory Affairs function. This position plays a key role in maintaining high-quality regulatory information, supporting compliance with global regulations, and enabling operational excellence through the Veeva RIM Vault platform.
This role is based in Hyderabad, India, and contributes directly to Amgen’s mission of serving patients by ensuring regulatory processes are accurate, efficient, and aligned with evolving global standards such as IDMP, EU CTR, and other emerging frameworks.
Experience Required
Candidates must meet one of the following criteria:
Master’s degree with 5–8 years of directly related experience
Bachelor’s degree with 6–9 years of experience in Regulatory Affairs, Regulatory Data Management, Clinical Documentation, Veeva RIM Vault, or related functions
Preferred Experience:
Advanced proficiency in Veeva Vault RIM
Experience with CTIS, IDMP, XeVMPD, or regulatory submission management
Experience working in global, matrixed environments
Exposure to process improvement or regulatory transformation projects
Key Responsibilities
Maintain and manage regulatory data within the Regulatory Information Management (RIM) system.
Create, update, and archive clinical trial submissions, marketing applications, and Health Authority correspondence.
Serve as a Data Management Subject Matter Expert (SME) in cross-functional initiatives.
Support implementation of new regulatory processes in Veeva Vault, XeVMPD, IDMP, and related systems.
Develop and deliver training materials on regulatory data standards and RIM workflows for global teams.
Generate and analyze reports for data quality and process streamlining initiatives.
Manage Protocol Amendment New Investigator (PANI) submission updates and Form FDA 1572 documentation.
Provide global support for Certificates of Pharmaceutical Product (CPP) and Certificates of Medicinal Product (CMP) during high workload periods.
Ensure full compliance with Amgen policies, SOPs, guidelines, and regulatory standards.
Collaborate with cross-functional and global teams to ensure consistent data governance and operational effectiveness.
Required Knowledge and Skills
Strong understanding of global clinical trial applications, marketing authorizations, and regulatory frameworks.
Solid working knowledge of Veeva Vault systems.
Excellent written and verbal communication skills.
Strong time management, prioritization, and attention to detail.
Ability to work independently with minimal supervision.
Effective teamwork, diplomacy, and ability to work well under pressure.
Strong analytical, problem-solving, and critical-thinking abilities.
Ability to understand business complexities and manage project interdependencies.
Proficiency in MS Office and relevant regulatory systems.
Ability to influence stakeholders across different levels in global teams.
Preferred Skills
Advanced expertise in Veeva Vault RIM.
Experience working in dynamic, technology-driven regulatory environments.
Ability to drive deadlines, support project completion, and motivate team members.
Experience collaborating with global and cross-functional teams.
Why Join Amgen
Amgen offers competitive Total Rewards, a collaborative global environment, and opportunities for continuous learning and advancement. Employees benefit from:
Comprehensive compensation and benefits
Career development resources
Supportive and innovation-driven work culture
How to Apply
Interested candidates can apply through the official Amgen careers portal. Applications remain open until a suitable candidate is selected.
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