Job Title: Sr. Associate Regulatory Affairs
Location: India – Hyderabad (On Site)
Job ID: R-207690
Date Posted: April 8, 2025
Category: Regulatory
Company: Amgen
Job Summary
Amgen is a leading biopharmaceutical company and is looking for a Sr. Associate in Regulatory Affairs to join their Regulatory Optimization of Tactical and Strategic Support (ROOTS2) team. This team is responsible for supporting CMC (Chemistry, Manufacturing, and Controls) and Device submissions for Amgen products across various stages of development and global markets.
Key Responsibilities
Lead the submission process for annual reports, facility registrations, and product renewals
Prepare CMC submission content plans including IND/CTAs, IDE/PSA, and marketing applications
Coordinate and collect country-specific documents for regulatory submissions
Document and archive all CMC submissions and related communications
Manage CMC product timelines and ensure they align with product development stages
Train staff on relevant procedures and systems
Interface with regulatory operations teams and cross-functional teams to ensure smooth submission execution
Report project status and activities to teams and department leaders
Required Skills and Experience
Master’s degree OR
Bachelor’s degree with 1-2 years of experience in regulatory CMC or QA/QC in the Pharmaceutical/Biotechnology industry
Associate’s degree with 6+ years of experience in manufacturing, QA/QC, or regulatory CMC
High school diploma/GED with 8+ years of experience in a regulatory CMC role
Strong communication skills and ability to work across teams and functions
Familiarity with Veeva Vault platforms
Preferred Qualifications
BS degree in Life Science
Experience in IVD, Device, or Combination Product regulatory submission
Strong project management and organizational skills
Regulatory CMC knowledge and experience
Why Join Amgen?
Impactful work: Contribute to global product registrations and support the advancement of therapeutic solutions
Collaborative culture: Work in an environment that encourages innovation, teamwork, and personal growth
Competitive benefits: Comprehensive benefits and opportunities for career development
How to Apply
Visit: careers.amgen.com
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