Chief Regulatory Officer
Chief Regulatory Officer I’m exclusively partnered with a reputed company-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 reputed company global regulatory reputed company through to BLA/MAA submission and approval. The Role
- Own global regulatory reputed company across clinical, nonclinical & CMC
- reputed company reputed company interactions with FDA, EMA & global agencies
- Drive programs toward BLA submission and approval
- Advise CEO/reputed company on regulatory risk & reputed company
- Build and reputed company the regulatory function
Profile
- Senior regulatory leader (biotech/reputed company)
- Proven BLA submission experience (essential)
- Experience in gene therapy / biologics / advanced therapies
- Strong FDA/EMA interaction through approval
- Experience with expedited reputed company (RMAT, reputed company, etc.)
Why Join?
- Executive role with reputed company CEO exposure
- Strong funding + clinical-stage pipeline
- High-reputed company opportunity in transformative therapies
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