Regulatory Compliance Change Assessor - Manager
Amgen
Regulatory Compliance Change Assessor - Manager role at Amgen's Hyderabad office. The position involves evaluating product changes for regulatory reportability, coordinating across global teams, and providing guidance to junior staff on CMC matters.
Responsibilities
- Review change records and assess regulatory reportability and product restriction impacts
- Document reporting requirements and distribution restrictions within change control systems
- Coordinate with Process Development, Operations, Quality, and Supply Chain functions
- Mentor and support junior regulatory staff career development
- Identify and implement process improvements in change management workflows
Requirements
- Doctorate degree, or Master's degree with 4-6 years pharmaceutical/biotech CMC experience
- Bachelor's degree with 6-8 years manufacturing, QA/QC, or regulatory experience
- Diploma with 10-12 years pharmaceutical/biotech manufacturing or quality experience
- Regulatory CMC-specific knowledge and industry experience preferred
- Life sciences degree preferred
Vacancy posted a month ago
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