Director, RA Global Regulatory Strategy
Core
Develop and implement global regulatory strategies to secure and maintain market approval for neuroscience products.
Role type
Senior IC regulatory strategy director
Builds
Global regulatory dossiers and product strategies
Domain
Life sciences / Neuroscience
Required skills
Global regulatory strategy, drug development lifecycle management, risk assessment and mitigation, cross-functional leadership, policy development, executive communication, project management, regulatory analysis
Preferred skills
Advanced degree in life sciences, 10+ years pharmaceutical regulatory experience, lead regulatory product strategist experience in multiple major regions (EU, Japan), global drug development business acumen
Technologies
Regulatory databases, project management tools
Responsibilities
Lead the Global Regulatory Product Team to develop creative global strategies; ensure strategic messaging in global regulatory dossiers; prepare global regulatory product strategies and risk mitigation plans; influence development of regulations and guidance; present regulatory assessments to executive management; manage project resourcing and budget allocations.
Seniority
Director, strategic leadership with direct reports