Senior Manager, Regulatory Affairs

CK GROUP ,
Hatfield, Hertfordshire
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Overview

CK Clinical are recruiting for a Senior Manager, Regulatory Affairs to join a global pharmaceutical company. This will be a permanent role based at their offices in Hertfordshire. The Role: The position involves supporting European regulatory activities for the companies neurology pipeline, which includes two compounds currently in Phase 3 development in early Alzheimer's Disease. Submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. The appointed person will also be the EU Regulatory Lead for an early phase compounds targeting rare epilepsies, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for the above. Requirements: BSc/MSc in relevant field. EU and/or UK regulatory processes and environment, including clinical trials. Regulatory strategy experience and strong strategic thinking skills. Experience with liaising and negotiating with regulatory authorities, both verbally and in writing. Experience with EU scientific advice, EU Paediatric Regulatory procedures and Orphan drugs. Desirable: some experience in neurosciences therapy area, development of Global Paediatric strategy(ies). Apply: Entitlement to work in the UK is essential. Please quote reference 47631 in all correspondence. This job was originally posted as www.totaljobs.com/job/89633948

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