Senior Director, Regulatory Strategy

Primary 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 

 

Additional Potential Regulatory CMC Responsibilities

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 scale‑up 
Control strategy evolution 
Manufacturing changes and comparability assessments 
Interpret and apply evolving global guidance related to gene therapy CMC 

Required Skills and Qualifications

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

Strongly Preferred Qualifications

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