Regulatory Compliance Change Assessor – Manager
Location: Hyderabad, India | On-Site | Job ID: R-227864**
Overview
Amgen is expanding its Regulatory Compliance function in India and is seeking a Regulatory Compliance Change Assessor – Manager to support global Chemistry, Manufacturing and Controls (CMC) regulatory activities across the product lifecycle. This role is responsible for assessing operational changes, determining regulatory reportability, and ensuring compliance with regional, national, and international licensing requirements.
The ideal candidate brings strong expertise in regulatory CMC, manufacturing, or quality assurance within the pharmaceutical or biotechnology industry, along with proven experience supporting cross-functional teams.
Key Responsibilities
Regulatory Assessment & Compliance
Review operational and product-related change records to determine regulatory reportability across global markets.
Assess product distribution restrictions and document regulatory requirements within the change control management system.
Maintain state and federal licenses for Amgen products in alignment with global regulatory expectations.
Provide support for products across modalities, development phases, and geographic regions.
Cross-Functional Collaboration
Partner with Process Development, Operations, Quality, Supply Chain, and Global RA CMC teams to ensure consistent regulatory alignment.
Support communication between site-level and global regulatory functions, including biosimilars and device regulatory teams.
Represent regulatory perspectives in decision-making processes that impact manufacturing, quality, or product lifecycle management.
Leadership & Process Improvement
Provide regulatory guidance to cross-functional and interdepartmental teams.
Coach and support junior regulatory staff, contributing to capability development across the organization.
Identify, recommend, and implement process improvements to strengthen the change management framework.
Experience Required
Candidates must meet one of the following educational and experience criteria:
Doctorate degree in a relevant field
OR
Master’s degree with 3 years of experience in manufacturing, QA/QC, or regulatory CMC within the pharmaceutical or biotechnology industry
OR
Bachelor’s degree with 5 years of experience in manufacturing, QA/QC, or regulatory CMC within the pharmaceutical or biotechnology industry
About Amgen
Amgen is a global biotechnology leader using advanced science, genetic insights, and modern technologies to discover, develop, and deliver breakthrough medicines. With more than four decades of innovation, Amgen remains committed to improving patient outcomes worldwide through high-quality research, development, and manufacturing.
This role supports Amgen’s mission by ensuring regulatory oversight, enabling global compliance, and supporting product development throughout the lifecycle.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Amgen provides reasonable accommodations for applicants with disabilities during the application process, interviews, and throughout employment.
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