VP, Regulatory Affairs Strategy
Core
Senior global regulatory strategist accountable for designing and executing integrated US, EU, and international regulatory strategies for AAV gene therapy programs from IND through BLA/MAA approval.
Role type
VP, Regulatory Affairs Strategy (Senior IC)
Builds
Integrated global regulatory strategies, submission plans, and evidence-generation strategies for gene therapy programs.
Domain
Biotechnology / Gene Therapy / Regulatory Affairs
Required skills
Global regulatory strategy, FDA CBER/OTP interaction, EMA interaction, BLA/MAA filing, viral vector gene therapy expertise, AAV development, expedited pathway identification, team leadership, risk assessment, cross-functional partnership
Preferred skills
Advanced degree (Ph.D., J.D., PharmD, MBA, M.S.), experience with novel endpoints and trial designs, experience with orphan/expedited designations, experience with Pre-Approval Inspection readiness
Technologies
AAV vectors, FDA CBER/OTP frameworks, EMA CAT/ATMP frameworks
Responsibilities
Develop integrated global regulatory strategies for AAV gene therapy programs; Design global development and submission sequencing; Build regulatory evidence strategies for novel endpoints; Serve as regulatory lead on program and governance teams; Identify and pursue expedited regulatory pathways; Plan and lead health authority interactions; Lead preparation of major submissions (INDs, BLAs, MAA); Partner with cross-functional teams to define submission content; Shape target product profiles and labeling strategy; Lead ex-US regulatory strategy execution; Build and develop the Regulatory Strategy team; Communicate regulatory strategies to executive leadership and the Board.
Seniority
VP, strategic leadership & team management