Manager, CMC Regulatory Affairs

Capricor Therapeutics(10 days ago)

San Diego, CAOnsiteFull TimeSenior$90,000 - $135,000Regulatory Affairs

About this role

Capricor Therapeutics is seeking a Manager of CMC Regulatory Affairs to oversee regulatory activities related to Chemistry, Manufacturing, and Controls for their cell and exosome-based therapies. The role involves ensuring compliance with global regulatory standards, preparing regulatory submissions, and collaborating with cross-functional teams to support product development and approval processes.

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Required Skills

Regulatory Affairs
Cmc Documentation
FDA
EMA
Biologics
Regulatory Strategy
Process Validation
Veeva RIM
Cross-functional Collaboration
Regulatory Submissions

Qualifications

BS in Pharmacy, Chemistry, Chemical Engineering, Life Sciences
5+ years in regulatory affairs
Experience with BLA submissions

About Capricor Therapeutics

capricor.com

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a San Diego–based biotechnology company developing cell- and exosome-based therapeutics for muscular and other select diseases. Its lead candidate, deramiocel (CAP‑1002), is an allogeneic cell therapy currently in Phase 3 clinical development for Duchenne muscular dystrophy. Capricor is also advancing exosome technology as a next‑generation platform, engineering exosomes to deliver nucleic acids and proteins to treat or prevent a variety of diseases. The company focuses on translating these platforms into novel therapeutic and preventive products.

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