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Job Location | London |
Education | Not Mentioned |
Salary | £450.00 - £550.00 per day |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract, full-time |
Regulatory Affairs Manager, EU, CTA, contract job Regulatory Affairs ManagerYour new company This small to medium sized pharma is looking for a Regulatory Affairs Manager to join a small Regulatory Affairs team in LondonYour new roleAs Regulatory Affairs Manager you will be responsible for ensuring all clinical trial applications and other clinical development activities meet current regulatory requirements/guidelines in the UK, EU and the USThe 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 submissionWhat youll need to succeedIn 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 applicationsWhat youll get in returnFlexible working options available.What you need to do nowFor more information on this or any other Regulatory Affairs contract jobs please apply to this advert and ask for Victoria Dunlop