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Director, Regulatory Affairs
OCUGEN OPCO INC
Amsterdam · On-siteLead (10+ years)OtherPosted 8 days ago
About the job
What you'll do
The Director will lead regulatory strategy and execution for gene therapy and ATMP programs across the EU and UK, managing interactions with the EMA and MHRA. They will provide strategic guidance throughout the product lifecycle and coordinate regulatory activities across cross-functional global teams.
What they're looking for
Candidates must have 10+ years of regulatory experience in biotechnology, specifically with innovative biologics, cell therapy, or gene therapy. An advanced degree in a relevant scientific or medical discipline is preferred, along with demonstrated experience in late-stage clinical development and major regulatory submissions.
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