EU Senior Global Reg Affairs Project Leader (m/f/d)
Core
Define and execute EU regulatory strategies, lead submissions, and serve as primary contact with EMA and National Competent Authorities for a global healthcare company.
Role type
Senior IC Regulatory Affairs Project Leader
Builds
Regulatory strategies, submission packages (IMPDs, PIPs, MAAs), and global Company Core Data Sheets
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU regulatory strategy, EMA interaction, regulatory submission management, scientific advice coordination, regulatory intelligence, project leadership, clinical development lifecycle knowledge
Preferred skills
Global regulatory strategy development, business development due diligence support, cross-functional team leadership
Technologies
None stated
Responsibilities
Define and execute EU regulatory strategies, lead preparation and execution of regulatory submissions, represent Regulatory Affairs on cross-functional teams, maintain regulatory intelligence, develop global regulatory strategies, lead regulatory sub-teams
Seniority
Senior, hands-on IC
