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New Jersey Department of Children and Families
Trenton, New Jersey
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Director, CMC Regulatory Affairs
PMV is seeking an experienced and motivated Director of Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) to lead the development and execution of CMC regulatory strategy for the Company’s assets. The Director, Regulatory Affairs-CMC will work closely with cross-functional teams, including other Regulatory functions, CMC, Quality Assurance, and external vendors) to ensure the successful submission of CMC dossiers and compliance with regulatory guidelines across regions throughout the product lifecycle. Responsibilities Act as Regulatory CMC Lead: Serve as the primary interface between CMC subject matter experts (SMEs) and Regulatory Affairs. Coordinate and lead all CMC regulatory projects, including budget, timelines,
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