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

Message me to learn more or apply directly.

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