Job Title: Regulatory Compliance Change Assessor – Manager
Location: India – Hyderabad
Job ID: R-227864
Work Location Type: On Site
Date Posted: November 03, 2025
Category: Regulatory
About Amgen
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and improve lives.
With over 40 years of leadership in biotechnology, Amgen continues to innovate using cutting-edge science and genetic data to create transformative medicines for millions of patients worldwide.
Job Purpose
The Regulatory Compliance Change Assessor – Manager is responsible for ensuring appropriate regulatory oversight and evaluation of reportability for changes throughout the product lifecycle.
This role supports product development, global registration, and compliance with regulatory agency expectations by facilitating the Regulatory Affairs – Chemistry, Manufacturing, and Controls (RA CMC) function.
Key Responsibilities
Review change records to assess the impact of changes with respect to regulatory reportability and product restrictions.
Define and document reporting and product distribution restriction requirements within the change control management system.
Collaborate with Process Development, Operations, Quality, and Supply Chain teams to ensure regulatory strategy alignment.
Provide regulatory expertise and guidance to interdepartmental and cross-functional teams.
Coach and mentor junior regulatory staff to support professional development.
Identify and implement process improvements to enhance the efficiency of change management activities.
Educational Qualifications
Doctorate degree
OR
Master’s degree with 3+ years of experience in manufacturing, QA/QC, or Regulatory CMC within the Pharmaceutical/Biotechnology industry
OR
Bachelor’s degree with 5+ years of experience in manufacturing, QA/QC, or Regulatory CMC within the Pharmaceutical/Biotechnology industry
Preferred Skills and Competencies
Deep understanding of Regulatory CMC principles and compliance requirements.
Proven experience in change management and cross-functional collaboration.
Strong analytical, communication, and leadership skills.
Ability to mentor, manage priorities, and drive continuous improvement initiatives.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer.
Applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Reasonable accommodations will be provided to individuals with disabilities for participation in the application or interview process, performance of essential functions, and access to benefits and privileges of employment.
Apply Now: [Amgen Careers – Apply]
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