Amgen is a global biotechnology leader committed to unlocking the potential of biology for patients suffering from serious illnesses. With a focus on innovative human therapeutics, Amgen leverages advanced technologies to deliver groundbreaking medicines. The company fosters a culture of integrity, collaboration, and relentless pursuit of excellence in science and patient care.
Job Description: Associate, Regulatory Data Management
Amgen is seeking a highly motivated Associate, Regulatory Data Management to join its Operations team in Hyderabad. This role ensures regulatory compliance by managing data flow across systems and processes.
Key Responsibilities:
- Maintain the Regulatory Information Management (RIM) system.
- Archive clinical trial submissions, marketing applications, and Health Authority correspondence in the RIM system.
- Act as a liaison between regulatory teams, CMC, safety, partners, and submission management.
- Generate, run, and analyze reports for data streamline projects.
- Assist in managing US CPP (Certificate of Pharmaceutical Product) and EU CMP (Certificate of Medicinal Product) during peak workload.
- Ensure compliance with Amgen’s SOPs, policies, and regulatory guidelines.
Required Skills & Qualifications:
✔ Highly organized, detail-oriented, and a strong team player.
✔ Familiarity with regulatory filings (FDA, EMA, MHRA).
✔ Knowledge of global clinical and regulatory requirements.
Preferred Skills:
✔ Experience with Veeva Vault platform.
✔ Understanding of regulatory data standards (IDMP).
Education & Experience:
- Master’s degree + relevant experience
OR - Bachelor’s degree + 2 years of experience
How to Apply
- Experience in regulatory submissions, RIM systems, Veeva Vault, or regulatory compliance is a plus.
- Freshers with a Master’s degree and good understanding of regulatory processes may be considered.
