What are the responsibilities and job description for the Chief Regulatory Officer position at Hartmann Young?
🚀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
đź“© Message me to learn more or apply directly.