Job Title: Manager – Regulatory Affairs (Site)
Location: Hyderabad, India
Job ID: R-222937
Work Type: On-site
Date Posted: August 29, 2025
Category: Regulatory
Amgen harnesses the best of biology and technology to tackle the world’s toughest diseases and enhance patients’ lives. Our Regulatory Affairs, Chemistry, Manufacturing, and Controls (RA CMC) team supports product development and global registration by developing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs across the product lifecycle.
The Regulatory Compliance Team within RA CMC ensures regulatory adherence by assessing operational changes, maintaining state and federal licenses, and supporting licensed products across development phases, modalities, and countries.
The Manager – Regulatory Affairs (Site) will be responsible for maintaining U.S. state and federal commercial product licenses and collaborating with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams to support strategies and activities impacting licensed products.
Conduct periodic assessments of licenses and facilities to ensure compliance with current regulations.
Monitor and evaluate new and existing regulations to maintain up-to-date compliance.
Communicate regulatory requirements to internal functional teams.
Obtain necessary documentation from internal and external partners.
Prepare, review, and submit license applications and renewals.
Maintain all State Licensing documentation, submissions, and interactions with State Authorities.
Interface with State Board of Pharmacy (BoP) and/or Department of Health (DoH).
Complete required annual notifications to the U.S. FDA.
Obtain DUNS and FEI numbers for new U.S. sites, as required.
Process financial obligations related to fee payments.
Identify and implement process improvements for state licensing processes.
Coach and support the career development of junior regulatory staff.
Basic Qualifications:
Doctorate degree OR
Master’s degree with 3+ years in manufacturing, QA/QC, or regulatory CMC in Pharmaceutical/Biotechnology industry OR
Bachelor’s degree with 5+ years in manufacturing, QA/QC, or regulatory CMC in Pharmaceutical/Biotechnology industry
Preferred Qualifications:
Degree in Life Sciences
Regulatory CMC-specific knowledge and experience
Experience in manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
Working knowledge of U.S. state and/or federal licensing requirements
Competitive base salary and comprehensive Total Rewards Plans aligned with local industry standards.
A collaborative work culture that supports professional and personal growth.
Opportunities to contribute to meaningful work that impacts patients globally.
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For a career that defies imagination, join us at Amgen. Objects in your future are closer than they appear.
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