Chief Regulatory Officer
Chief Regulatory Officer I’m exclusively partnered with a well-funded, clinical-stage gene therapy company advancing a pipeline of rare diseases. They’re looking for a Chief Regulatory Officer (CRO) to report to the CEO and lead global regulatory strategy through to BLA/MAA submission and approval. The Role
- Own global regulatory strategy across clinical, nonclinical & CMC
- Lead all interactions with FDA, EMA & global agencies
- Drive programs toward BLA submission and approval
- Advise CEO/Board on regulatory risk & strategy
- Build and lead the regulatory function
Profile
- Senior regulatory leader (biotech/pharma)
- Proven BLA submission experience (essential)
- Experience in gene therapy / biologics / advanced therapies
- Strong FDA/EMA interaction through approval
- Experience with expedited pathways (RMAT, Breakthrough, etc.)
Why Join?
- Executive role with direct CEO exposure
- Strong funding + clinical-stage pipeline
- High-impact opportunity in transformative therapies
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