Senior Manager, Regulatory Operations
Core
Plan, coordinate, and drive execution of regulatory submissions and program timelines for gene editing therapies to global health authorities.
Role type
Senior Manager, Regulatory Operations
Builds
Regulatory submission packages (INDs/CTAs, BLAs/MAAs) and briefing materials for FDA, EMA, and other global agencies.
Domain
Biotechnology / Gene Editing / Regulatory Affairs
Required skills
Regulatory submission planning, IND/CTA/BLA/MAA management, eCTD structure, project management, cross-functional coordination, document management systems, risk management, vendor management
Preferred skills
Gene therapy/gene editing regulatory experience, rare disease/orphan drug development, expedited programs (Breakthrough Therapy, Fast Track, RMAT), global agency experience (EMA, MHRA, etc.), PMP certification, advanced degree (MS, PharmD, PhD)
Technologies
eCTD, Veeva Vault RIM, regulatory publishing tools, document management systems
Responsibilities
Lead end-to-end planning and execution of regulatory submissions; Develop and maintain integrated regulatory timelines and track milestones; Partner with cross-functional teams to compile and finalize submission content; Support preparation for health authority meetings; Track and coordinate responses to health authority information requests; Manage regulatory publishing and document management systems; Maintain regulatory operations SOPs and tracking systems; Support management of regulatory operations vendors and budget
Seniority
Senior Manager, hands-on leadership