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Walker Cole International is searching for a Regulatory Affairs Manager to join a global pharmaceutical company. As the Regulatory Affairs Manager you will be responsible for EU regulatory activities including lifecycle management, submissions to EU regulatory bodies, preparing for new MAAs and developing regulatory strategy (throughout product lifecycle).
The main responsibilities of the Regulatory Affairs Manager will include:
The successful candidate will:
Regulatory Affairs | RA | GMP | Pharmaceutical | Regulatory | Submission | Dossiers | EU | Global | EMA | Good Manufacturing Practice | CTD | Common Technical Documentation | eCTD | Electronic Common Technical Documentation | Module 1 | MAA | Marketing Authorization Application | Variations | SmPC | Summary of Product Characteristic | PIL | Product Information Leaflet