Sr. Associate Regulatory Affairs Hiring at Amgen Hyderabad

Sr. Associate Regulatory Affairs Hiring at Amgen Hyderabad: Join a Global Biotech Leader

Amgen, a Fortune 500 biotechnology pioneer, is expanding its Regulatory Affairs team in Hyderabad. The company is currently hiring for the Sr. Associate Regulatory Affairs position, offering a unique opportunity to contribute to groundbreaking therapies that improve lives worldwide. If you have a background in regulatory CMC, pharmaceutical manufacturing, or quality assurance, this role is your chance to grow with a global leader in biotech innovation.

About Amgen
Amgen has been at the forefront of scientific discovery for over four decades, developing transformative medicines for patients battling serious illnesses. Amgen continues to lead the biotechnology industry with a strong commitment to innovation and excellence, delivering life-changing therapies to millions globally.

Job Overview

• Job Title: Sr. Associate Regulatory Affairs
• Location: Hyderabad, Telangana, India
• Work Location Type: On-Site
• Job ID: R-205850
• Date Posted: February 03, 2025
• Category: Regulatory

Key Responsibilities
As a Sr. Associate Regulatory Affairs at Amgen, you will be pivotal in supporting Chemistry, Manufacturing, and Controls (CMC) submissions. Your responsibilities will include:

• Leading submissions for annual reports, facility registrations, and product renewals.
• Collaborating with authors, reviewers, and subject matter experts to deliver CMC documents for regulatory submissions.
• Preparing submission content plans for CMC IND/CTAs, marketing applications, and post-market supplements.
• Coordinating and legalizing country-specific CMC documents.
• Documenting and archiving CMC submissions in the company’s management system.
• Training staff on CMC procedures and systems.
• Participating in cross-functional project teams to drive regulatory success.

Qualifications
To be considered for this role, candidates must meet the following criteria:

Basic Qualifications:

• Master’s degree OR
• Bachelor’s degree with 1-2 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
• Associate’s degree with 6 years of relevant experience OR
• High school diploma/GED with 8 years of experience in the field.

Preferred Qualifications:

• Bachelor’s degree in Life Sciences or a related field.
• Experience in manufacturing, process development, quality assurance, or analytical development.
• Strong project management and organizational skills.
• Excellent oral and written communication skills.
• Familiarity with Veeva Vault platforms is a plus.

How to Apply
Ready to take the next step in your career? Apply now for the Sr. Associate Regulatory Affairs position at Amgen Hyderabad. Click here to submit your application: Apply Now.

Tagged as: Global Pharma Jobs, Pharmaceutical Careers, Pharmaceutical Jobs