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

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    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-submissions
    • Prepare all CTR-related documentation and be responsible for uploading this to the CTIS portal
    • Act as an SME for the CTIS portal advising on how to use this system
    • Participate in EU-CTR consulting and contributing to its operational implementation
    • Drive EU CTR submissions, amendments, and strategies
    • Provide leadership and expertise in regulatory and submissions-related aspects of clinical trials
    • Offer guidance on submissions expertise to junior team members
    • Facilitate transversal collaboration between departments for the timely delivery of all submissions of complex large clinical trials

    Skills and Experience required:

    • A degree in a scientific discipline
    • Background in clinical trial management
    • Experience in Regulatory Affairs
    • Good level of knowledge of Clinical Trial Submissions on a local and regional level
    • Working knowledge of submissions under EU-CTR directive
    • Solution-oriented and problem-solving skills
    • Customer-oriented and able to work in a team as well as autonomously
    • Fluent 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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