Job Title:
Regulatory Affairs Manager (RA CMC)
Department:
Regulatory
Company:
Amgen
Location:
Hyderabad, India
Work Location Type:
On Site
Date Posted:
April 8, 2025
Application Deadline:
Not specified
Job ID:
R-207691
Job Summary:
Amgen is hiring a Regulatory Affairs Manager in Regulatory Affairs – Chemistry, Manufacturing and Controls (RA CMC). The role is part of the ROOTS2 (Regulatory Optimization of Tactical and Strategic Support) team, which supports global regulatory submission execution across the product lifecycle and modalities. The role includes project leadership, regulatory strategy execution, and direct interaction with global and site-based RA CMC teams.
Key Responsibilities:
Lead regulatory submissions for:
Annual reports
Facility registrations/renewals
Product renewals
Potential oversight or management of junior staff
Act as a key contact for submission execution or reporting activities
Develop and maintain regulatory process documentation
Train and onboard new team members
Coordinate with cross-functional teams and SMEs for CMC documentation
Prepare/oversee CMC submission content plans:
IND/CTAs, IDE/PSA/CIA, marketing applications, post-market supplements, Module 3 baselines, annual reports
Manage CMC country-specific documents and legalization
Document and archive submissions in document management systems
Initiate and maintain timelines for CMC/Device submissions
Interface with regulatory operations and cross-functional teams
Participate in special project teams and status reporting
Basic Qualifications:
One of the following:
Doctorate degree OR
Master’s degree + 5 years in manufacturing, QA/QC, or regulatory CMC (Pharma/Biotech) OR
Bachelor’s degree + 7 years in manufacturing, QA/QC, or regulatory CMC (Pharma/Biotech)
Preferred Qualifications:
BS degree in Life Sciences
Experience managing or mentoring staff
Experience in:
Manufacturing
Process Development
Quality Assurance/Control
Analytical Development
Regulatory submission experience in IVD, Device, or Combination Products
Strong Regulatory CMC knowledge
Project management and organizational skills
Effective written and verbal communication
Experience using Veeva Vault platforms
About Amgen:
Amgen is a Fortune 500 biotechnology company with over 40 years of scientific innovation. It serves millions of patients globally and is committed to advancing medicine and transforming lives. The company fosters a collaborative, inclusive, and science-driven culture.
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