Manager Regulatory Affairs (EU)
Core
Lead regulatory activities and strategies for oncology and rare disease products across EU and international markets.
Role type
Manager, Regulatory Affairs
Builds
Regulatory submissions, strategies, and processes for life-changing medicines
Domain
Biopharmaceuticals, Oncology, Rare Diseases
Required skills
Regulatory strategy, cross-functional coordination, process development, inspection support, deadline management, matrix working
Preferred skills
Approved-product regulatory leadership, CMC knowledge, Oncology or rare disease experience
Technologies
Regulatory databases
Responsibilities
Manage regulatory activities for assigned products, Coordinate global teams and local entities, Develop SOPs and work instructions, Represent Regulatory Affairs in cross-functional forums, Support inspections and clinical trial applications, Ensure compliance with company standards
Seniority
Manager, hands-on leadership