Regulatory Affairs – CMC (ROOTS2 Team)
📍 Location: India – Hyderabad (On-Site)
🆔 Job ID: R-224555
📅 Date Posted: September 01, 2025
📂 Category: Regulatory
About Amgen
Amgen is a leading biotechnology company with more than 40 years of experience in advancing human therapeutics. As a Fortune 500 organization, Amgen harnesses scientific discovery and innovation to fight serious illness and improve patients’ lives worldwide.
About the Role
The Regulatory Affairs, Chemistry, Manufacturing, and Controls (RA CMC) team plays a vital role in supporting product development and global registrations. Amgen’s Regulatory Optimization of Tactical and Strategic Support (ROOTS2) team in India supports CMC and/or Device submission execution across development phases, modalities, and countries.
As a member of ROOTS2, you will:
Interface with Global, Site, Biosimilars, and/or Device RA CMC teams.
Support or lead projects depending on your experience.
Contribute to regulatory strategies and ensure effective execution of submission deliverables.
Key Responsibilities
Lead submissions for annual reports, facility registrations/renewals, and product renewals.
Coordinate with authors, reviewers, and SMEs for preparation of CMC/Device regulatory documents.
Develop submission content plans for:
CMC IND/CTAs and amendments
IDE/PSA/CIA applications
New marketing applications
Post-market supplements/variations
Module 3 baselines
Facility registrations/renewals
Annual reports/notifications
Prepare, collect, and legalize country-specific CMC documents.
Document and archive submissions and communications in the document management system.
Initiate and maintain timelines under product lead direction.
Collaborate with Regulatory Operations.
Train staff on selected procedures and systems.
Provide regular status reports on activities and projects.
Participate in cross-functional project teams.
Basic Qualifications
Master’s degree
OR
Bachelor’s degree + 1–2 years’ experience in manufacture, QA/QC, or regulatory CMC
OR
Associate’s degree + 6 years’ relevant experience
OR
High school diploma/GED + 8 years’ relevant experience
Preferred Qualifications
Bachelor’s degree in Life Sciences.
Experience in Manufacture, Process Development, QA, QC, or Analytical Development.
Knowledge of IVD, Device, or Combination Product regulatory submissions.
Strong understanding of Regulatory CMC processes.
Proven project management and organizational skills.
Excellent oral and written communication skills.
Experience with Veeva Vault platforms.
Why Join Amgen?
Contribute to advancing innovative therapies for serious illnesses.
Work in a science-driven, entrepreneurial culture.
Be part of a global team that impacts millions of patients worldwide.
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Siliguri |Illinois :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Kyiv |Lima Region :
Lima |France :
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Niš |Bohemia :
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