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CMC Regulatory Strategy Lead — Biologics (Remote)

Travere Therapeutics

San Diego, CA
  • Remote job

Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for global CMC activities across development and commercial programs, with a focus on biologics and rare diseases. You will partner with cross-functional teams to align CMC plans with regulatory requirements, lead global submissions (INDs, NDAs), and drive lifecycle management from late development through post-approval. #J-18808-Ljbffr Travere Therapeutics

Vacancy posted 4 days ago
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