Senior Specialist, Regulatory Affairs Manager EP
Core
Manage regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products, medical devices, and food supplements across multiple regions.
Role type
Senior Specialist, Regulatory Affairs Manager
Builds
Marketing authorizations and regulatory submissions for pharmaceutical and veterinary products
Domain
Pharmaceutical industry, European Union regulatory affairs
Deliverable
client delivery
Required skills
EU regulatory procedures (CP, DCP, MRP), global regulatory submissions, lifecycle management, EMA engagement, regulatory intelligence, project planning and execution, budget reporting
Preferred skills
Consultancy on regulatory strategy, VDC strategy implementation, commercial proposal input
Technologies
None stated
Responsibilities
Develop and maintain client relationships, participate in regulatory processes for marketing authorizations, prepare and review regulatory documents, communicate with Health Authorities, plan and execute client projects, provide regulatory guidance, share regulatory intelligence, support VDC strategy, ensure compliance with internal procedures, provide operational insights for commercial activities, report on budget and project insights
Seniority
Senior, hands-on IC
