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Sr. Associate – Regulatory Affairs (Ra Cmc)

2-6 years years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Full Time Education: Bachelor’s degree in Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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