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    Regulatory Clinical Strategy - England, United Kingdom - Clinical Professionals Limited

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    Description

    Reference Number: JO
    Regulatory Clinical Strategy & Submissions Manager
    Rate: Negotiable
    Job Type: Contract
    Location: Maidenhead

    Regulatory Clinical Trial Strategy & Submissions Manager

    12 month contract

    Berkshire based – Hybrid working

    Offering up to £45.00 Per Hour via PAYE

    ASAP start

    CPL Life Sciences have been lucky enough to partner with a truly innovative pharmaceutical company supporting in providing medicines across immunology, oncology & neuroscience. Working initially on a 12 month contract the Regulatory Clinical Trial Strategy & Submissions Manager will be delivering Regulatory CTA strategies and operations. The preferred candidate with have a background with EU CTR experience.

    Job Responsibilities include;

    – Deliver CTA regulatory strategies & operations for a designated portfolio of development compounds

    – Ensure study deliverables are achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial legislation (including the EU Clinical Trial Regulation) and company procedures.

    – Assess scientific data provided by subject matter experts against CTA regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses

    – Author EU Clinical Trial Application forms, review CTA documents to ensure compliance with current requirements

    Candidate Requirements include;

    – Eligible to live and work in the United Kingdom

    – Life Sciences degree or equivalent qualification

    – Must be able to commit to commuting Berkshire office twice per week

    – Must have previous experience with EU CTR or CTIS

    – Preference for 5 years experience with Regulatory Affairs

    If this opportunity if of interest please email your up to date CV to

    #J-18808-Ljbffr


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