Amgen is Hiring a Regulatory Affairs Senior Associate in Hyderabad

Amgen, a global leader in biotechnology, invites talented professionals to join our Regulatory Affairs team. We’re hiring a Senior Associate for our Hyderabad facility to ensure compliance in our cutting-edge API manufacturing. Be part of a mission to improve lives through innovative medicines.

Walk-in Interview Details for Hyderabad

While the original posting doesn’t specify a walk-in event, applications are open for this on-site role. Apply by visiting Amgen Careers or emailing your resume to careers@amgen.com.

The position is based in Hyderabad, India, at Amgen’s state-of-the-art facility. This full-time role (Job ID: R-224599) awaits passionate candidates.

Amgen, with 40+ years in biotech, holds international accreditations like USFDA, ensuring excellence in pharmaceutical manufacturing.

Why Choose Amgen for Your Career?

Join a company dedicated to advancing science and patient care. Our Hyderabad site supports global product development through robust regulatory strategies.

Amgen fosters an inclusive, collaborative culture, certified as a Great Place to Work. Enjoy competitive benefits and growth opportunities in regulatory affairs.

Your work will support life-changing therapies, aligning with Amgen’s values of ethics, diversity, and innovation in the fight against serious diseases.

Available Position: Regulatory Affairs Senior Associate (Site)

This role focuses on ensuring compliance for Amgen’s products across development phases. You’ll maintain U.S. state and federal licenses and collaborate with global teams.

• Department: Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC)
• Location: Hyderabad, India (On-Site)
• Experience: 2–6 years, depending on education

Qualifications:

• Master’s degree OR
• Bachelor’s degree + 2 years in manufacturing, QA/QC, or regulatory CMC in pharma/biotech OR
• Associate’s degree + 6 years in similar roles

Preferred Qualifications:

• Degree in Life Sciences
• Knowledge of regulatory CMC and U.S. licensing requirements
• Experience in pharma/biotech manufacturing, testing, or distribution

Key Responsibilities:

• Track and maintain U.S. state and federal product licenses.
• Communicate requirements to internal Amgen teams.
• Obtain supplemental documentation from partners.
• Prepare, review, and submit license applications/renewals.
• Manage State Licensing documentation and interactions with State Boards of Pharmacy or Departments of Health.
• Complete annual FDA notifications.

How to Apply for Regulatory Affairs Jobs

Apply online at Amgen Careers for Job ID R-224599. Submit your CV highlighting regulatory CMC or QA/QC experience.

For inquiries, contact Amgen’s HR at careers@amgen.com. Follow Amgen on LinkedIn for updates and prepare to discuss your regulatory expertise.

Verified Regulatory Affairs Job Post

The post is released by the Amgen Webpage. Click here to visit the post

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Amgen is an Equal Opportunity Employer, ensuring accommodations for individuals with disabilities. Contact HR for support during the application process.

Final Call: Launch Your Biotech Career with Amgen

Don’t miss this opportunity to join a pioneer in biopharmaceuticals. As a Regulatory Affairs Senior Associate, you’ll drive compliance for global therapies.

Apply now to shape the future of healthcare with Amgen in Hyderabad. Your career in regulatory affairs starts here!