Senior Director, Regulatory Strategy
About The Position
The Senior Director, Regulatory Strategy will provide global regulatory leadership for AAV gene therapy development programs with an emphasis on early-stage clinical development. This role is responsible for defining and executing integrated regulatory strategies that align with corporate objectives, development timelines, and evolving global regulatory expectations for gene therapy products. The ideal candidate will have deep experience leading global regulatory programs and extensive interaction with FDA, EMA, and other major health authorities. Strong preference will be given to candidates who also have regulatory CMC experience that could fill a dual role leading regulatory CMC.
Requirements
- 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
Nice To Haves
- Regulatory CMC experience, particularly with gene therapy or other biologics
- Familiarity with accelerated pathways (RMAT, PRIME, Breakthrough Therapy)
- Experience in rare disease development
- Prior experience in a biotech or emerging company environment
Responsibilities
- 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
- Provide regulatory leadership for CMC strategy, particularly for AAV vector manufacturing, analytical control strategies, comparability, and lifecycle changes
- Partner closely with CMC, technical operations, and quality teams to align regulatory expectations with manufacturing realities
- Lead or contribute to regulatory strategies for:
- Process development and scaleâ up
- Control strategy evolution
- Manufacturing changes and comparability assessments
- Interpret and apply evolving global guidance related to gene therapy CMC
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
