Director, Regulatory Affairs Strategy - Genetics Medicine
Core
Lead global regulatory strategy and filings for genetic medicine products, serving as a key cross-functional partner and subject matter expert for regulatory approvals.
Role type
Director, Regulatory Affairs Strategy (Genetic Medicine)
Builds
Regulatory submissions (IND/CTA/BLA) and strategic plans for genetic medicine programs
Domain
Biotechnology / Genetic Medicine / Global Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, IND/CTA/BLA submission leadership, health authority interaction, cross-functional team leadership, CRO management, regulatory document preparation, program prioritization, mentoring
Preferred skills
Advanced degree in scientific discipline, experience with ex-US/ex-EU CTAs, ability to operate in ambiguous environments
Technologies
None stated
Responsibilities
Interpret regulatory authority feedback and communicate strategic implications; lead development of regulatory strategic plans; resolve complex regulatory issues; ensure quality and timeliness of submissions; lead health authority interactions; represent regulatory affairs at senior meetings; oversee regulatory activities and compliance; mentor and develop regulatory staff
Seniority
Director, people management & strategy