Regulatory CMC Director — Biologics/MSAT (Remote/NC)

Posted yesterday

tg therapeuticsBrooklyn (NY)

Regulatory Affairs Managers Biological Product (except Diagnostic) Manufacturing

SENIORITY

Manager

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About the role

TG Therapeutics, Inc. is seeking an Associate Director/Director/Sr. Director, Regulatory CMC to lead global CMC regulatory strategy and submissions for clinical and commercial products. This role reports to the VP of Regulatory CMC and collaborates with Quality, Technical Operations, and external partners to ensure compliance and timely filings. The candidate will oversee IND/BLA/CMC submissions, provide risk mitigation guidance, and manage cross-functional teams across regions, helping drive

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