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Chief Regulatory Officer

Hartmann Young - Boston, MA

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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 RoleOwn global regulatory strategy across clinical, nonclinical & CMCLead all interactions with FDA, EMA & global agenciesDrive programs toward BLA submission and approvalAdvise CEO/Board on regulatory risk & strategyBuild and lead the regulatory function?? ProfileSenior regulatory leader (biotech/pharma)Proven BLA submission experience (essential)Experience in gene therapy / biologics / advanced therapiesStrong FDA/EMA interaction through approvalExperience with expedited pathways (RMAT, Breakthrough, etc.)?? Why Join?Executive role with direct CEO exposureStrong funding + clinical-stage pipelineHigh-impact opportunity in transformative therapies?? Message me to learn more or apply directly.

Created: 2026-05-09

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