Chief Regulatory Officer Job at Hartmann Young, Boston, MA

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  • Hartmann Young
  • Boston, MA

Job Description

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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