Senior Director, Regulatory Strategy
Scorpion Therapeutics, New York, NY, United States
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