Jobs

    Regulatory Affairs Associate - Surrey, United Kingdom - EPM Scientific

    EPM Scientific
    EPM Scientific Surrey, United Kingdom

    3 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Regulatory Affairs Associate

    The Regulatory Affairs Associate will be responsible for:


    • Managing the clinical trial applications in Europe and other selected countries


    • Keeping up to date with regulatory and legal changes in EU


    • Preparing pre- and post-authorisation regulatory documentation and applications


    • Assisting in marketing access activities including pricing/contracts/product listings


    • Providing general regulatory advice to company's staff

    Based in the UK, the Regulatory Affairs Associate is expected to;


    • Prepare and/or collate all documentation to support clinical trial applications in Europe and other selected countries in close cooperation with the Clinical department,


    • Submit applications to competent authorities and ethics committees in Europe and other selected countries,


    • Prepare responses to questions raised by ethics committees and competent authorities and update documentation as required,


    • Manage the labelling of investigational medicinal product in compliance with regulatory labelling requirements,


    • Obtain approval for clinical trials,


    • File substantial amendments as required,


    • Assist with updating the Investigator Brochure and Investigational Medicinal Product Dossier

    Assist in the development of the ongoing global regulatory strategy


    • Submissions of marketing authorisation applications and variations


    • Prepare response to questions raised by competent authorities


    • Applications and submissions to national regulatory authorities as required


    • Submissions following post approval obligations and commitments


    • Maintain all approvals current by submitting annual updates as needed

    ESSENTIAL REQUIREMENTS FOR ROLE


    • Post-graduate qualifications in Pharmacy, Biological Sciences, or related disciplines.


    • Pharmaceutical industry experience


    • Preparation of clinical trial applications


    • High level of personal integrity and ethical behaviour


    • Strong attention to detail and time management


    • Strong written and communication skills

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