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Amgen, a global leader in biotechnology, is hiring a Regulatory Affairs Sr Associate (Site) in Hyderabad, India. This role is part of the Regulatory Affairs Chemistry, Manufacturing and Controls (RA CMC) – Compliance Team, which ensures smooth regulatory strategies, product licenses, and effective collaboration with agencies.
If you have experience in pharmaceutical manufacturing, QA/QC, or regulatory CMC and want to advance your career in regulatory affairs, this is a golden opportunity.
Key Responsibilities
As a Regulatory Affairs Sr Associate, your responsibilities will include:
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- Tracking and ensuring all licenses remain valid and effective.
- Communicating licensing requirements to internal teams.
- Preparing, reviewing, and submitting license applications and renewals.
- Maintaining documentation and submissions for US state licensing.
- Interfacing with US State Boards of Pharmacy (BoP) and Departments of Health (DoH).
- Obtaining supplemental documents from internal and external partners.
- Completing required annual FDA notifications.
Required Qualifications
Basic Qualifications:
- Master’s degree, OR
- Bachelor’s degree with 2+ years of experience in manufacturing, QA/QC, or regulatory CMC, OR
- Associate’s degree with 6+ years of relevant experience.
Preferred Qualifications:
- Degree in a Life Science discipline.
- Regulatory CMC-specific knowledge and experience.
- Experience in pharma/biotech manufacturing, QC/QA, or distribution.
- Familiarity with US federal and state licensing requirements.
Benefits at Amgen
Amgen offers competitive Total Rewards Plans, aligned with industry standards. Employees can expect:
- Professional growth opportunities.
- Collaborative and inclusive workplace culture.
- Comprehensive benefits covering personal and professional well-being.
How to Apply
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