Job Title: Senior Associate – Data Management
Location: Hyderabad, India (On-Site)
Job Type: Full-Time
Job ID: R-230494
Department: Regulatory Affairs
At Amgen, our mission to serve patients drives every initiative. As one of the world’s leading biotechnology companies, we are dedicated to researching, manufacturing, and delivering innovative therapies that reach over 10 million patients globally. Joining Amgen means contributing to meaningful work that impacts lives while growing your career in a collaborative, innovative environment.
The Senior Associate – Data Management will lead critical initiatives within Veeva RIM Vault, supporting regulatory compliance across global markets. This role is pivotal in ensuring data integrity, compliance with regulations such as IDMP, EU CTR, and emerging regulatory requirements, and streamlining global regulatory processes. Acting as a subject matter expert (SME) in Veeva RIM Vault, the Senior Associate will collaborate with cross-functional teams, support process implementation, and develop training to ensure teams are equipped to meet evolving regulatory demands.
Maintain and manage data within the Regulatory Information Management (RIM) system.
Create, archive, and manage clinical trial documents, marketing application submissions, and health authority correspondence in Veeva Vault.
Serve as a Data Management SME in cross-functional regulatory initiatives.
Implement new processes within Veeva Vault, XeVMPD, IDMP, and other regulatory systems ensuring global compliance.
Generate, analyze, and report data for streamlining projects.
Develop and deliver training materials and presentations to global audiences.
Manage Protocol Amendment New Investigator (PANI) submission updates.
Maintain 1572 forms for FDA submissions.
Support US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) submissions during workload peaks.
Ensure compliance with Amgen SOPs, policies, and regulatory guidelines.
Master’s degree with 5-8 years of relevant experience, or Bachelor’s degree with 6-9 years of relevant experience in regulatory data management or life sciences.
Deep understanding of Veeva Vault RIM system and regulatory submission processes.
Familiarity with Global Clinical Trial Applications, Marketing Authorizations, and regulatory guidance.
Strong analytical, problem-solving, and critical thinking skills.
Excellent verbal and written English communication skills.
Independent, detail-oriented, and capable of managing multiple priorities.
Ability to work collaboratively in global, cross-functional teams.
Proficiency in Microsoft Office and other relevant software.
Practical experience with CTIS system.
Experience in global matrix organizations and dynamic, evolving environments.
Strong training and mentorship capabilities.
Adaptability to new technologies and regulatory processes.
Competitive Total Rewards package aligned with local industry standards.
Collaborative, inclusive work culture promoting professional growth.
Opportunities to contribute to global regulatory strategy and patient impact.
Supportive environment with flexibility and emphasis on employee well-being.
Amgen is an Equal Opportunity Employer. We welcome applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodations are available throughout the application and employment process.
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