Job Title:
Sr. Associate – Regulatory Affairs (RA CMC)
Job Information:
Job ID: R-224555
Location: India – Hyderabad
Work Type: On-site
Date Posted: September 01, 2025
Category: Regulatory
Company: Amgen
About Amgen:
Amgen is a global biotechnology leader with more than 40 years of experience in advancing human therapeutics through scientific discovery and innovation. As a Fortune 500 company, Amgen’s mission is to help millions of people fight serious illnesses. We are science-driven, patient-focused, and committed to making a meaningful impact in global healthcare.
Department Overview:
Regulatory Affairs – Chemistry, Manufacturing and Controls (RA CMC) plays a pivotal role in supporting product development, manufacturing, and global registration. The ROOTS2 (Regulatory Optimization of Tactical and Strategic Support) team is part of RA CMC and focuses on submission execution across product modalities, development phases, and global markets.
Amgen India is expanding the ROOTS2 team in Hyderabad, offering a chance to contribute to global regulatory submissions and processes.
Role Summary:
The Sr. Associate – Regulatory Affairs will support or lead RA CMC and/or Device submission execution for Amgen products. The role involves direct collaboration with Global, Site, Biosimilars, and Device RA CMC teams, based on product-specific strategies and priorities.
Key Responsibilities:
Regulatory Submission Execution:
Lead or support:
Annual reports
Facility registrations/renewals
Product renewals
Prepare submission content plans for:
INDs/CTAs and amendments
Marketing applications
IDEs/PSAs/CIAs (Device-related)
Post-market supplements/variations
Module 3 baselines and annual notifications
Coordinate and legalize country-specific documents for CMC submissions
Document and archive regulatory submissions and communications in document management systems
Project Coordination:
Maintain product timelines as directed by product leads
Interface with Regulatory Operations to ensure timely submission execution
Train peers on selected systems and procedures
Provide status updates for activities and projects
Participate in cross-functional special projects
Basic Qualifications (any one of the following):
Master’s degree, OR
Bachelor’s degree with 1–2 years of experience in Manufacturing, QA/QC, or Regulatory CMC in the Pharmaceutical/Biotech industry, OR
Associate’s degree with 6 years of related experience, OR
High school diploma/GED with 8 years of relevant industry experience
Preferred Qualifications:
Bachelor’s degree in Life Sciences
Experience in:
Manufacturing, Process Development, Quality Assurance/Control
Analytical Development
IVD, Device, or Combination Product regulatory submissions
Regulatory CMC frameworks and documentation
Strong project management and organizational skills
Effective written and oral communication abilities
Experience with Veeva Vault or similar regulatory platforms
Why Join Amgen:
Be part of a global regulatory team contributing to impactful medical innovations
Work in a diverse, inclusive, and collaborative environment
Access to career development and training opportunities
Competitive benefits and rewards
Apply Now:
Click Here to Apply
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