Kategória: Munka, állás
Honlap:
Részletek...Location: Budapest, Hungary Job type: Permanent, full-time Hybrid working About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Role Overview: the EU Platform Regulatory Coordinator is responsible for providing submission excellence support for lifecycle management (LCM) activities for all EU regulatory procedures, including Centralized Procedures (CP), Mutual Recognition Procedures (MRP), Decentralized Procedures (DCP), and Worksharing initiatives, while providing additional operational support to other Key Markets countries (Switzerland, Israel). Main responsibilities: Regulatory Operations Coordination: Coordinate all centralized EU regulatory operational non-core LCM activities across the Sanofi portfolio Serve as the primary excellence partner and contact point for GBU Regulatory Strategists, EU regulatory affiliates and key regulatory stakeholders including CMC and labelling strategists Manage and coordinate labelling variations, initial variations, and responses to requests for supplementary information Oversee established centralized EU activities (e.g., Article 23 procedures) Process Excellence & Knowledge Management Maintain and enhance current regulatory repositories and ensure training materials and Ways of Working (WoWs) remain current with evolving internal processes and updated EU regulations
