Amgen Inc. is looking for a Regulatory Affairs Sr Associate (Site) to join our team in India. In this role, you will be responsible for maintaining U.S. state and federal commercial product licenses and collaborating with cross-functional teams on strategies impacting licensed products. You will be part of an inclusive, highly accomplished group dedicated to improving lives.

What You'll Do

Track license status to ensure all are current and effective.
Communicate requirements to internal Amgen functional teams.
Obtain supplemental 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 FDA.

What We're Looking For

Master’s degree
OR Bachelor’s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
OR Associate’s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Nice to Have

Degree in a Life Science discipline
Regulatory CMC specific knowledge & experience
Experience in manufacture, testing (QC/QA or clinical), or distribution in the Pharmaceutical/Biotech industry
Working knowledge of US state and/or federal licensing requirements

Team & Environment

You will be part of the Regulatory Compliance team within RA CMC, collaborating closely with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams.

Benefits & Compensation

Competitive and comprehensive Total Rewards Plans aligned with local industry standards

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.