Job Title: Regulatory Affairs Manager
Location: India – Hyderabad (On Site)
Job ID: R-207691
Date Posted: April 8, 2025
Category: Regulatory
Company: Amgen
Job Summary
Amgen, a leading biotechnology company, is seeking a Regulatory Affairs Manager to join the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) team. This team plays a pivotal role in supporting CMC (Chemistry, Manufacturing, and Controls) and Device submissions for Amgen products across global markets and product development stages. As a Regulatory Affairs Manager, you will drive regulatory submission execution, lead projects, and ensure compliance with regulatory requirements.
Key Responsibilities
Lead the submission process for annual reports, facility registrations, facility renewals, and product renewals
Oversee and manage staff, providing training and onboarding
Coordinate and prepare CMC submission content plans including IND/CTAs, IDE/PSA, new marketing applications, facility registrations, and more
Interact with subject matter experts and cross-functional teams for the preparation of regulatory submission documents
Manage product timelines for CMC and/or Device submissions
Maintain documentation of CMC and Device submissions and related communications
Participate in cross-functional project teams and communicate project statuses
Provide training on CMC procedures and systems to staff
Required Skills and Experience
Doctorate degree OR
Master’s degree with 5+ years of experience in regulatory CMC or QA/QC in the Pharmaceutical/Biotechnology industry
Bachelor’s degree with 7+ years of experience in manufacturing, QA/QC, or regulatory CMC
Strong experience in project management and staff management
Proficient in Veeva Vault and other relevant regulatory tools
Preferred Qualifications
BS degree in Life Science
Experience managing staff and overseeing regulatory submission processes
Knowledge in IVD, Device, or Combination Product regulatory submissions
Strong organizational, communication, and problem-solving skills
Why Join Amgen?
Impactful work: Help shape the future of biopharmaceutical products and ensure regulatory compliance across global markets
Collaborative culture: Join a dynamic team where innovation, growth, and diversity are prioritized
Competitive benefits: Comprehensive benefits package with opportunities for career advancement
How to Apply
Visit: careers.amgen.com
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