Global Regulatory Lead
Core
Develop and lead innovative, science-driven global regulatory strategies for assigned products across the product lifecycle, serving as the primary Global Regulatory Affairs representative on Product Strategy Teams.
Role type
Senior Director, Global Regulatory Strategy
Builds
Integrated global regulatory strategies, briefing books, and regulatory documents for biopharmaceutical products
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Required skills
Global regulatory strategy, FDA/EMA engagement, cross-functional leadership, strategic decision influence, regulatory document development, team management, regulatory intelligence
Preferred skills
Advanced degree (MS/PhD/MD/MBA), clinical development expertise, medical device expertise, matrix organization navigation
Technologies
None stated
Responsibilities
Develop global regulatory strategies, lead cross-functional partnerships, drive health authority engagement, provide regulatory leadership and oversight, influence product development decisions, lead strategic regulatory deliverables, drive regulatory intelligence and innovation, promote global regulatory alignment, lead and develop talent
Seniority
Director, strategic leadership with hands-on execution