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Regulatory Affairs Consultant - Slough, Berkshire, United Kingdom - Cpl Life Sciences
Description
Job Title:
Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35)
Job Type: 12-month contract Location: Berkshire, UK –
Hybrid Pay Rate:
£65-75 per hour (PAYE)We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis. You will work as a Regulatory EU CTR SME and support several EU CTR submissions. As a Regulatory Affairs Professional, you will assume a crucial role in providing leadership and expertise in all regulatory and submission-related aspects of clinical trials. You will serve as the main point of contact and be responsible for delivering submission-specific milestones while offering guidance on submission strategies. Additionally, you will actively participate in EU-CTR consulting and contribute to the operational implementation aspects of the EU-CTR directive, ensuring effective collaboration between departments. Your role may also involve serving as a Clinical Trial Submission Coordinator/Lead, overseeing complex large clinical trial submissions.
Responsibilities:
Lead/support all CTR initial submissions, transitions, amendments, and re-submissionsPrepare all CTR-related documentation and be responsible for uploading this to the CTIS portalAct as an SME for the CTIS portal advising on how to use this systemParticipate in EU-CTR consulting and contributing to its operational implementationDrive EU CTR submissions, amendments, and strategiesProvide leadership and expertise in regulatory and submissions-related aspects of clinical trialsOffer guidance on submissions expertise to junior team membersFacilitate transversal collaboration between departments for the timely delivery of all submissions of complex large clinical trialsSkills and Experience required:A degree in a scientific disciplineBackground in clinical trial managementExperience in Regulatory AffairsGood level of knowledge of Clinical Trial Submissions on a local and regional levelWorking knowledge of submissions under EU-CTR directiveSolution-oriented and problem-solving skillsCustomer-oriented and able to work in a team as well as autonomouslyFluent in English is a must (written and spoken)You must be able to be based on site 3x a week in Berkshire, UK, and have the FULL right to work in the UK.
