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

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    Description
    Regulatory Clinical Strategy & Submissions Manager

    Job Type:
    Contract

    Regulatory Clinical Trial Strategy & Submissions Manager
    12 month contract
    Berkshire based – Hybrid working
    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.

    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
    Must be able to commit to commuting Berkshire office twice per week
    – Preference for 5 years experience with Regulatory Affairs


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