Amgen is seeking a highly motivated Associate, Regulatory Data Management to join its team in Hyderabad. In this role, you will ensure the compliance of regulatory data by managing the smooth and compliant flow of information across systems and processes.
Key Roles & Responsibilities:
- Provide support in maintaining the Regulatory Information Management (RIM) system.
- Create and archive clinical trial submissions, marketing applications, and Health Authority correspondence in the RIM system.
- Act as a point of contact between regulatory representatives, CMC, safety teams, partners, and submission management teams.
- Assist in creating, running, and analyzing reports for data streamline projects.
- Support the data management global team in handling US CPP (Certificate of Pharmaceutical Product) and EU CMP (Certificate of Medicinal Product) during peak workload periods.
- Ensure adherence to Amgen’s processes, policies, SOPs, and training documentation.
Required Skills & Qualifications:
- Highly motivated, organized, and detail-oriented team player.
- Familiarity with regulatory procedures and filings.
- Knowledge of global clinical & regulatory requirements (FDA, EMA, MHRA, etc.).
Preferred Skills:
- Working knowledge of Veeva Vault platform (preferred).
- Experience with regulatory data standards (e.g., IDMP).
Education & Experience:
- Master’s degree + some related experience OR
- Bachelor’s degree + 2 years of related experience OR
- Associate’s degree + 4 years of related experience OR
- High school diploma / GED + 5+ years of related experience
About Amgen
Amgen is a global biotechnology leader committed to transforming lives through innovative medicines. The company focuses on serious illnesses by leveraging advanced human genetics to deliver cutting-edge therapies. With a strong presence in Hyderabad, Amgen fosters a collaborative and inclusive work environment, offering employees opportunities for growth and development.
Why Join Amgen?
- Work in a globally recognized biotech firm.
- Engage in impactful regulatory data management.
- Be part of a supportive and innovative team.
- Opportunities for career advancement and skill development.
How to Apply
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