Director, CMC Regulatory Affairs

Capricor Therapeutics(10 days ago)

San Diego, CAOnsiteFull TimeSenior$150,000 - $200,000Regulatory Affairs

About this role

Capricor Therapeutics is seeking a Director of CMC Regulatory Affairs to lead and develop regulatory strategies for their cell and exosome-based therapies throughout their product lifecycle. The role involves collaborating with cross-functional teams and engaging with health authorities to ensure compliance and successful regulatory submissions.

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Required Skills

Regulatory Strategy
CMC
Biologics
Cell Therapies
FDA
EMA
ICH Guidelines
Regulatory Submissions
Process Validation
Team Leadership

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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