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Director, Regulatory Affairs

Scorpion Therapeutics

Boston, MA

Role: Senior Director of Regulatory Strategy leading regulatory affairs and health authority interactions for gene therapies at Genetix Biotherapeutics.

Responsibilities
  • develop and execute global regulatory strategies, support FDA and EMA engagements, lead lifecycle management, and oversee regulatory submissions for products in clinical and post-approval stages
  • partner cross-functionally with Medical Affairs, Clinical, CMC, Quality, and Commercial teams
  • manage regulatory teams and external consultants
Requirements
  • advanced degree in life sciences, 10+ years industry experience, 6+ years in regulatory affairs, proven success in FDA interactions and major US submissions
  • experience with biologics, cell, and gene therapies
  • strong regulatory knowledge including ICH countries and EU processes
Preferred
  • direct gene therapy experience, BLA approval support, PIPs, and European regulatory expertise
High-Value
  • focus on gene therapies, lifecycle management, FDA and EMA engagement, regulatory leadership for global product development, and strategic planning for market access
Work setup

hybrid in Somerville, MA, with candidates within commuting distance.

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Vacancy posted 4 days ago
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