Reg Compliance Change Assessor (Senior Associate)
Location: Hyderabad, India | Work Type: On-Site | Job ID: R-227866
Category: Regulatory Affairs
Job Overview
Amgen is expanding its Regulatory Compliance function in India and is seeking a Reg Compliance Change Assessor (Senior Associate) to support global CMC (Chemistry, Manufacturing and Controls) regulatory activities. This role plays an essential part in assessing operational changes, determining global reportability requirements, and ensuring compliance across multiple development phases and product modalities.
The position reports to the Regulatory Compliance Team Lead and collaborates with global, site-level, biosimilar, and device regulatory teams, as well as Operations, Quality, and Supply Chain functions. This role is ideal for professionals looking to expand their regulatory expertise in a highly structured, global biotechnology environment.
Key Responsibilities
Regulatory Change Assessment
Review operational change records to determine global regulatory reportability and product distribution restrictions.
Define and document regulatory reporting requirements within Amgen’s change control management system.
Support regulatory decisions for single-product and cross-product changes across multiple regions.
Cross-Functional Alignment
Collaborate with Process Development, Operations, Quality, and Supply Chain departments.
Ensure alignment with established regulatory strategies and global compliance expectations.
Provide regulatory insights to cross-functional and interdepartmental stakeholders.
Process Optimization
Identify gaps and drive improvements within the change management process.
Contribute to efficiency initiatives related to regulatory reporting workflows.
Experience Required
Candidates must meet one of the following criteria:
Master’s degree in a relevant scientific or technical field
OR
Bachelor’s degree with 2 years of experience in manufacturing, QA/QC, or regulatory CMC within the pharmaceutical or biotechnology industry
OR
Associate’s degree with 6 years of experience in manufacturing, QA/QC, or regulatory CMC within the pharmaceutical or biotechnology industry
Preferred Experience
Degree in a Life Science discipline
Prior experience in Regulatory CMC
Hands-on experience in pharmaceutical or biotech manufacturing, QC/QA testing, or product distribution
About the Role
This position supports regulatory compliance throughout the product lifecycle and ensures Amgen’s global products meet all reporting requirements. The Senior Associate will work across teams to strengthen regulatory documentation, maintain product quality compliance, and contribute to efficient change management operations.
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, disability, or protected veteran status. The company provides reasonable accommodations for candidates with disabilities throughout the hiring process.
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