"Amgen Hiring Regulatory Affairs Senior Associate in Hyderabad, India – Apply Now"
 |
(Amgen Hiring Regulatory Affairs)
|
Are you an experienced professional in
Regulatory Affairs, CMC, QA/QC, or pharmaceutical manufacturing? Amgen, a
global biotechnology leader, is inviting applications for the position of
Regulatory Affairs Senior Associate at its Hyderabad, India office. This opportunity is perfect for candidates passionate about regulatory compliance, pharmaceutical licensing, and ensuring patient safety through global healthcare standards.
About the Role – Regulatory Affairs Senior Associate:-
As a part of Amgen’s Regulatory team, you will play a key role in ensuring compliance with U.S. federal and state licensing requirements while supporting global product safety and regulatory excellence.
Key Responsibilities:
- Track and maintain U.S. state and federal commercial product licenses.
- Communicate compliance requirements with internal stakeholders.
- Collect and review supplemental documentation from internal/external partners.
- Prepare, review, and submit license applications and renewals.
- Maintain licensing submissions and liaise with State Board of Pharmacy (BoP) and Department of Health (DoH).
- Complete FDA annual notifications as per compliance requirements.
Qualifications Required:-
To apply for this position, candidates must meet one of the following criteria:
- Master’s degree in a Life Science discipline OR
- Bachelor’s degree + 2 years of relevant experience in Regulatory CMC, QA/QC, or pharma/biotech manufacturing OR
- Associate’s degree + 6 years of relevant industry experience
Preferred Skills:
- Solid knowledge of Regulatory CMC processes
- Experience in pharmaceutical or biotech manufacturing, testing, or distribution
- Familiarity with U.S. state and federal licensing requirements
Why Join Amgen?
Working at Amgen offers you an opportunity to grow with one of the world’s most innovative biotechnology companies.
- Competitive salary with a Total Rewards package
- Inclusive, diverse, and collaborative workplace culture
- Continuous learning and career development opportunities
- A chance to contribute to life-changing biotechnology solutions for patients worldwide
How to Apply:-
Interested candidates can apply online through the official Amgen careers portal:
👉 Apply Here – Amgen Regulatory Affairs Senior Associate
FAQs:-
Q: Where is this position located?
A: The role is based in Hyderabad, India.
Q: What background is ideal for this role?
A: Professionals with experience in Regulatory CMC, QA/QC, or pharmaceutical manufacturing will be the best fit.
Q: Does Amgen provide career growth opportunities?
A: Yes, Amgen offers professional training, development programs, and global exposure for long-term career growth.
This article is SEO-optimized with relevant keywords like Regulatory Affairs Jobs in India, Pharma Jobs in Hyderabad, Amgen Careers, QA/QC Jobs, Biotechnology Jobs India, etc., making it suitable for Google ranking.
Share on WhatsApp
🖇️ Related job opportunities:
Amgen Regulatory Affairs Senior Associate Jobs in Hyderabad 2025
Genpact Associate – Triage Data Surveillance Specialist Job in Gurugram
