EU Senior Global Reg Affairs Project Leader (m/f/d)
Core
Define and execute EU regulatory strategies, lead submissions (IMPDs, PIPs, MAAs), 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
EU regulatory submissions, global regulatory strategies, and Company Core Data Sheets
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
EU regulatory frameworks, EMA interaction, clinical development lifecycle, project leadership, regulatory intelligence
Preferred skills
Global regulatory strategy, business development due diligence
Technologies
IMPDs, PIPs, Orphan Drug Applications, MAAs, variations, life-cycle updates, Company Core Data Sheet
Responsibilities
Define EU regulatory strategies, coordinate with EMA/National Authorities, lead Scientific Advice meetings, oversee submissions, ensure labeling compliance, represent Regulatory Affairs on cross-functional teams, maintain regulatory intelligence, contribute to due diligence, develop global strategies, lead sub-teams, support affiliates
Seniority
Senior, hands-on IC