Manager Regulatory Affairs
Core
Shape EU regulatory strategy and support timely clinical development for life-changing medicines in serious diseases.
Role type
Manager, Regulatory Affairs (EU)
Builds
EU regulatory strategies and clinical study submissions
Domain
Life Sciences / Pharmaceuticals / EU Regulatory
Required skills
EU regulatory strategy, clinical study submissions, agency query management, stakeholder negotiation, written and verbal communication, EU legislation monitoring, relationship building with regulatory agencies
Preferred skills
European Medicines Agency experience, orphan designation, paediatric investigation plans
Technologies
None stated
Responsibilities
Develop EU-appropriate regulatory strategies, lead clinical study submissions and agency queries, represent company with contract research organisations, monitor emerging EU legislation, build relationships with European Medicines Agency and national agencies, lead early and late-stage regulatory strategy
Seniority
Manager, hands-on IC