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Amgen, a global biotechnology leader, is seeking a Regulatory Affairs Senior Associate in Hyderabad, India. This role is ideal for professionals with experience in Regulatory CMC, QA/QC, pharmaceutical manufacturing, and compliance. If you are passionate about ensuring product safety, regulatory excellence, and advancing healthcare, this could be your next career-defining opportunity.
Key Responsibilities
As a Regulatory Affairs Sr Associate at Amgen, you will:
- Track and maintain U.S. state and federal commercial product licenses.
- Communicate compliance requirements to internal teams.
- Collect supplemental documentation from internal and external partners.
- Prepare, review, and submit license applications and renewals.
- Maintain state licensing submissions and interact with state authorities.
- Interface with State Board of Pharmacy (BoP) and Department of Health (DoH).
- Complete required FDA annual notifications.
Required Qualifications
- Master’s degree in a Life Science discipline OR
- Bachelor’s degree + 2 years of experience in manufacturing, QA/QC, or regulatory CMC (pharma/biotech) OR
- Associate’s degree + 6 years of relevant industry experience
Preferred Skills
- Strong knowledge of Regulatory CMC processes
- Experience in pharmaceutical/biotech manufacturing, testing, or distribution
- Working knowledge of U.S. state and federal licensing requirements
Benefits of Working at Amgen
At Amgen, you can expect:
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- Competitive salary and Total Rewards package aligned with industry standards
- Inclusive and collaborative workplace culture
- Professional growth and development opportunities
- A mission-driven role where your work directly impacts patient lives
Application Process
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