Senior Director, Regulatory Strategy

Role Overview:

• Function as the global regulatory lead for early stage programs and participate in and advise global development teams.
• Lead the strategy and preparation of key regulatory objectives and documents such as Fast Track, RMAT, PRIME, and health authority meetings.
• Monitor the evolving regulatory landscape for gene therapy and proactively advise internal stakeholders on global regulatory guidelines and requirements.

Additional 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.

Required Skills:

• Proven experience with global regulatory submissions (IND/CTA/BLA).
• Direct experience with FDA and EMA meetings and interactions.
• Excellent interpersonal and verbal and written communication skills; strong presentation skills.