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CMC Regulatory Affairs Manager — Drive First-Pass Approvals
Job in
North Chicago, Lake County, Illinois, 60086, USA
Listed on 2026-08-27
Listing for:
BioSpace
Full Time
position Listed on 2026-08-27
Job specializations:
-
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Abb Vie in North Chicago, IL is seeking a Manager, Regulatory Affairs for CMC to lead regulatory strategies and submissions, collaborating with RA, R&D and Operations to drive first-pass approvals. You will mentor teams and align products with evolving regulatory requirements.
Responsibilities include developing CMC strategies for INDs/CTAs and amendments, managing submission content, and building strong relationships with global agencies while guiding complex programs through lifecycle
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