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Regulatory Submissions Lead - FDA/BLA/IND
Job in
Elizabeth, Union County, New Jersey, 07215, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-08-30
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Scorpion Therapeutics is seeking a Manager of Regulatory Affairs Operations to support global regulatory submissions with a focus on U.S. FDA programs. You will coordinate content plans, timelines, and lifecycle management, ensuring BLA/IND readiness.
You will partner with CMC, Nonclinical, Clinical, and Labeling teams to align submissions, perform quality checks, and manage records in RIMS, while advancing Veeva RIM adoption and eCTD standards.
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