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Senior CMC Regulatory Affairs Lead — First-Pass Strategy
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-08-17
Listing for:
AbbVie
Full Time
position Listed on 2026-08-17
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Abb Vie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions across INDs/CTAs and amendments. You will partner with R&D, Operations and product teams to ensure timely, compliant filings and first-pass approvals, while guiding cross-functional teams through evolving regulatory landscapes.
The role emphasizes strategic liaison with agencies like the FDA, strong communication skills, and leadership in a matrix environment.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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