About this role

Function as the global regulatory lead for early stage programs and participate in and advise global development teams
Define and lead the Regulatory strategy for early-stage gene therapy programs (pre-IND through Phase 1/2)
Lead preparation for and participation in global health authority interactions, including FDA (CBER), EMA, and other regional agencies
Lead the strategy and preparation of key regulatory objectives and documents such as Fast Track, RMAT, PRIME, and health authority meetings (INTERACT, Pre-IND, PDUFA meetings, scientific advice, etc.).
Proactively identify and communicate potential risks and define mitigation strategies
Monitor the evolving regulatory landscape for gene therapy and proactively advise internal stakeholders on global regulatory guidelines and requirements
Lead and manage the preparation and publication of regulatory submissions
Oversee regulatory activities conducted by CROs to ensure alignment with overall strategy

Advanced degree in a scientific discipline is strongly preferred
Minimum 10 years of experience in Regulatory Affairs
Proven experience with global regulatory submissions (IND/CTA/BLA)
Direct experience with FDA and EMA meetings and interactions
Strong leadership experience
Excellent interpersonal and verbal and written communication skills; strong presentation skills
Excellent planning and organizational skills
Ability to travel monthly to NY HQ if not local to the area

Senior Director, Regulatory Strategy

Key skills