Regulatory Compliance Change Assessor - Manager

Amgen · Hyderabad, India

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Role summary

Regulatory Compliance Change Assessor - Manager role at Amgen's Hyderabad office. Assess product changes for regulatory reportability and restrictions, coordinate across global teams, and mentor junior staff in pharmaceutical compliance.

What they're looking for

Doctorate in life science, or Master's with 4-6 years pharma/biotech CMC experience
Bachelor's degree with 6-8 years manufacture, QA/QC, or regulatory CMC experience
Diploma with 10-12 years pharmaceutical or biotechnology manufacturing/QA experience
Regulatory CMC-specific knowledge and expertise
Understanding of scientific and technical principles in pharmaceutical/biotech field

What you'll be doing

Evaluate change records for reportability impact and product distribution restrictions
Document reporting requirements and restrictions in change control management systems
Liaise with Process Development, Operations, Quality, and Supply Chain for regulatory alignment
Provide expertise and guidance to cross-functional teams on regulatory strategies
Coach and support junior regulatory staff development and identify process improvements

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Date posted16 days ago

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