Regulatory Compliance Change Assessor – Manager
Location: Hyderabad, India
Category: Regulatory
Work Type: On-Site
Job ID: R-227864
Amgen is expanding its Regulatory Compliance team in India and is seeking an experienced Regulatory Compliance Change Assessor – Manager to support global Chemistry, Manufacturing and Controls (CMC) regulatory oversight across the product lifecycle. This role is central to ensuring regulatory reportability, alignment with global compliance standards, and effective coordination with cross-functional teams.
About Amgen
Amgen is a global leader in biotechnology, dedicated to leveraging science, data, and innovation to develop transformative therapies. With more than 40 years of pioneering work, Amgen continues to advance cutting-edge medicines that serve millions of patients worldwide.
Position Overview
The Regulatory Compliance Change Assessor – Manager will support regulatory oversight for product and manufacturing changes, ensuring regulatory requirements are met across global markets. The role includes evaluating change records, defining reportability strategies, maintaining state and federal licenses, and serving as a key partner to Regulatory Affairs CMC teams, Quality, Operations, Supply Chain, and Product Development.
This role also includes coaching junior regulatory staff, driving operational improvements, and contributing to the continuous enhancement of change management processes.
Key Responsibilities
Review change records and assess regulatory reportability requirements across products and markets.
Define, document, and update regulatory reporting and product distribution restrictions for assigned changes within the change control management system.
Collaborate with Process Development, Operations, Quality, Supply Chain, and global RA CMC teams to ensure alignment on regulatory strategies and impact assessments.
Provide subject-matter expertise and regulatory guidance to cross-functional teams.
Support and mentor junior regulatory staff, contributing to capability building and career development.
Identify opportunities to streamline and strengthen the change management process and drive continuous improvement initiatives.
Support global compliance activities across product modalities, including biologics, biosimilars, and medical devices.
Experience & Qualification Requirements
Candidates must meet one of the following educational and experience pathways:
Doctorate degree
OR
Master’s degree with 3+ years of experience in manufacturing, QA/QC, or Regulatory CMC in the pharmaceutical or biotechnology industry
OR
Bachelor’s degree with 5+ years of experience in manufacturing, QA/QC, or Regulatory CMC in the pharmaceutical or biotechnology industry
Additional preferred skills include:
Strong understanding of global CMC regulatory principles
Experience in change management and regulatory impact assessments
Ability to collaborate effectively across technical, operational, and regulatory teams
Strong analytical, documentation, and communication skills
Ability to manage multiple priorities in a compliance-driven environment
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All applicants will be considered without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status, or disability. Reasonable accommodations will be provided upon request throughout the application and employment process.
Apply Now
Advance your career in global regulatory compliance and contribute to Amgen’s mission of delivering innovative therapies that transform patient lives.
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