Global Regulatory Affairs Director - Inflammation and Rare Disease
Core
Lead the Global Regulatory Team to develop and execute global regulatory strategies for product development, registration, and lifecycle management in Inflammation and Rare Disease.
Role type
Senior Director, Global Regulatory Affairs
Builds
Global regulatory strategies, registration plans, and submission documents for biologic medicines
Domain
Biotechnology / Inflammation and Rare Disease
Required skills
Global regulatory strategy development, team leadership, regulatory agency interaction, lifecycle management, risk identification, strategic planning
Preferred skills
Team building, scientific communication, conflict resolution, cultural awareness, complex decision making, negotiation
Technologies
Regulatory submission systems, clinical trial management tools
Responsibilities
Develop and execute global regulatory product strategy, lead GRTs, represent Regulatory on product teams, develop registration strategies, lead global regulatory filings, monitor global regulations, ensure consistent product communication, attend regulatory agency meetings
Seniority
Director, strategic leadership & team management