Senior Associate – Data Management (Regulatory Operations)
Location: Hyderabad, India
Job ID: R-230494
Category: Regulatory
Work Type: On-Site
About the Role
Amgen is seeking a Senior Associate, Data Management to support regulatory information management initiatives across global markets. This role plays a critical part in ensuring compliance with evolving global regulatory frameworks, including IDMP, EU CTR and related standards. The position requires deep expertise in the Veeva RIM Vault system and strong capability in implementing streamlined, compliant data management processes.
The Senior Associate will work across functional teams to maintain accurate regulatory information, lead data standards development, support global filings, and contribute to training and process improvement initiatives. This is a key role within Amgen’s Regulatory Operations team, ensuring efficient, compliant and high-quality data governance.
Key Responsibilities
Maintain and manage regulatory data within the Regulatory Information Management (RIM) system.
Create and archive clinical trial submissions, marketing application submissions and Health Authority correspondence within the RIM platform.
Serve as a Data Management Subject Matter Expert (SME) in cross-functional regulatory initiatives.
Lead and support implementation of new processes within Veeva Vault, XeVMPD, IDMP and other regulatory data standards.
Generate and analyze reports to support global data streamlining projects.
Develop and deliver training materials and presentations for global regulatory teams.
Manage Protocol Amendment New Investigator (PANI) submission updates.
Oversee FDA Form 1572 management for regulatory submissions.
Support global data teams during peak workloads, including US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) processes.
Ensure strict adherence to Amgen policies, procedures, guidelines, SOPs and training documentation.
Required Knowledge & Skills
Strong understanding of global clinical trial applications, marketing authorizations and regulatory guidance.
In-depth expertise with Veeva Vault systems and RIM data structures.
Excellent written and verbal communication skills.
High attention to detail and strong organizational abilities.
Ability to prioritize, manage time independently and work with minimal supervision.
Capable of working in demanding situations with professionalism, tact and diplomacy.
Strong analytical, problem-solving and presentation skills.
Ability to influence stakeholders across global, matrixed teams.
Proficiency in relevant software tools and data management applications.
Experience contributing to regulatory projects and improvement initiatives.
Fluency in English (written and verbal).
Preferred Knowledge & Skills
Advanced expertise in Veeva Vault RIM.
Experience working in dynamic, technology-driven environments.
Prior experience in global or matrix organizations.
Strong follow-through and ability to motivate others toward deadlines.
Education & Experience Requirements
Basic Requirements
Master’s Degree with 5–8 years of directly related experience
OR
Bachelor’s Degree with 6–9 years of directly related experience
Preferred Requirements
Practical experience with the CTIS system.
Why Join Amgen?
Amgen offers a collaborative and science-driven work environment, focused on career development and global impact. Employees benefit from competitive Total Rewards plans, development opportunities and a culture that values integrity, innovation and patient-focused outcomes.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and considers all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Reasonable accommodations are provided throughout the hiring process and employment lifecycle.
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