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Regulatory Affairs Sr Manager, CMC Strategy Lead Remote
Remote / Online - Candidates ideally in
Deerfield, Lake County, Illinois, 60063, USA
Listed on 2026-08-24
Deerfield, Lake County, Illinois, 60063, USA
Listing for:
BioSpace
Remote/Work from Home
position Listed on 2026-08-24
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Amgen seeks a Regulatory Affairs Senior Manager to lead CMC regulatory strategies for investigational and marketed products. You will coordinate with Technical Operations, R&D, Commercial and other stakeholders on submissions and Health Authority interactions.
The role requires a Masters in Regulatory Science and at least 6 years in regulatory roles, with expertise in preparing briefing documents and CMC content for submissions while ensuring compliance with FDA and global guidelines.
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