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    Regulatory Affairs Consultant - Slough, United Kingdom - Cpl Life Sciences

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    Job Title:

    Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35)nJob Type:
    12-month


    contractnLocation:

    Berkshire, UK – HybridnPay 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:
    nLead/support all CTR initial submissions, transitions, amendments, and re-submissionsnPrepare all CTR-related documentation and be responsible for uploading this to the CTIS portalnAct as an SME for the CTIS portal advising on how to use this systemnParticipate in EU-CTR consulting and contributing to its operational implementationnDrive EU CTR submissions, amendments, and strategiesnProvide leadership and expertise in regulatory and submissions-related aspects of clinical trialsnOffer guidance on submissions expertise to junior team membersnFacilitate transversal collaboration between departments for the timely delivery of all submissions of complex large clinical trials

    Skills and Experience required:
    nA degree in a scientific disciplinenBackground in clinical trial managementnExperience in Regulatory AffairsnGood level of knowledge of Clinical Trial Submissions on a local and regional levelnWorking knowledge of submissions under EU-CTR directivenSolution-oriented and problem-solving skillsnCustomer-oriented and able to work in a team as well as autonomouslynFluent 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.

    For more information or to apply please reach out to

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