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Hays Specialist Recruitment Limited
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London, Greater London
Regulatory Affairs Manager
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Salary: £450 per day |
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Overview
Regulatory Affairs Manager, EU, contract job, CTA Regulatory Affairs Manager Your new company This small to medium sized pharma is looking for a Regulatory Affairs Manager to join a small Regulatory Affairs team in London Your new role The Regulatory Affairs Manager is responsible for compiling core regulatory packages for use in EU& UK clinical trial applications (CTAs) and compile complete CTAs for submission to UK and IE Competent Authorities and providing appropriate oversight of Service Providers making CTA submissions on behalf of the business. You will coordinate and track responses from and to Competent Authorities as well as plan and provide support for the compilation of Investigational New Drug (IND) application documentation for submission What you'll need to succeed In order to be considered for this Regulatory Affairs Manager contract job you should have experience of clinical trial applications in the rest of the EU and/or US and the flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment. Experience of late phase development and/or MAA submissions in EU or US desirable as well as experience of preparation of orphan, US Fast Track, Breakthrough or Prime applications What you need to do now For more information on this or any other Regulatory Affairs contract jobs please apply to this advert and ask for Victoria Dunlop