Regulatory Project Manager - FSP - EMEA
Core
Senior Manager of Regulatory Affairs leading strategic initiatives for global regulatory compliance across medical devices, pharmaceuticals, biologics, and in-vitro diagnostics.
Role type
Senior Manager, Regulatory Affairs
Builds
Regulatory strategies supporting product development, registration, and lifecycle management
Domain
Life Sciences / Regulatory Affairs
Required skills
Global regulatory strategy, submission preparation (IND, BLA, NDA, 510(k), CE marking), regulatory authority interaction, GMP/QMS compliance, project management, team leadership
Preferred skills
Life Sciences/Chemistry/Engineering/Pharmacy background, regulatory affairs certifications, additional languages beyond English
Technologies
Regulatory information management systems
Responsibilities
Guide regulatory activities across multiple product lines, develop and implement regulatory strategies, lead submission preparations, interact with regulatory authorities, manage regulatory intelligence activities, collaborate with cross-functional teams, manage and develop regulatory affairs staff
Seniority
Senior, hands-on IC with leadership responsibilities