Director, Regulatory Strategy Lead Europe
Core
Define and drive EU regulatory strategy for Immunology & Cardiovascular medicines from early development through registration and lifecycle management.
Role type
Director, European Regulatory Strategy Lead
Builds
Integrated submission plans and operational deliverables for EU registration
Domain
Life Sciences / Regulatory Affairs / Immunology & Cardiovascular
Required skills
EU regulatory strategy, Health Authority negotiations (EMA), cross-functional matrix leadership, scientific/medical background, risk management
Preferred skills
Immunology and/or cardiovascular therapeutic area experience
Technologies
Regulatory submission systems, EMA platforms
Responsibilities
Lead negotiations with EMA and Health Authorities, build integrated submission plans, provide authoritative regulatory guidance to Development Team Leaders, monitor evolving European regulatory trends, build relationships with Health Authorities and partners
Seniority
Director, strategic leadership