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    Senior Regulatory Affairs Associate - Munich, Deutschland - Cpl Life Sciences

    Cpl Life Sciences
    Cpl Life Sciences Munich, Deutschland

    vor 2 Wochen

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    Beschreibung

    Job Title: Senior Regulatory Affairs Officer (Maternity Cover)

    Location: Munich, Germany – (Hybrid)

    Remuneration: €45,000 - €55,000

    Senior Regulatory Affairs Officer opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the small team and lead several Regulatory Affairs activities for an established generics portfolio.

    This role will have a main focus on European submissions through MRP, DCP, and National procedures and also support UK and IRE submissions.

    Please note that this is a 12 month fixed-term contract and will be looking for the right person to start this position in June 2024. The position will be a maternity cover FTC and you will be responsible for managing regulatory submissions, new registrations, and variations applications for a range of different generic products marketed in the UK, IRE, and Europe.

    Responsibilities

    • Manage required regulatory processes for UK and European products including submitting submissions through National MRP and DCP.
    • Support all pre-submission meetings including inputting into scientific advice meetings.
    • Be responsible for all initial/new MAA applications into main EU countries.
    • Following MA approvals ensure product maintenance including submission of national variations or notifications.
    • Ensure EU and UK product labelling approval and compliance with the MA approval activities.
    • Successfully interact with the MHRA and any EU UK Regulatory Authority. Ensuring that regulatory processes are completed and products are launched in line with regulatory requirements.
    • Generate and implement local procedures and processes to ensure regulatory compliance is met for EU and UK portfolios.

    Requirements

    • A degree or higher in Life Sciences or technical field.
    • 4 to 8 years of relevant regulatory experience especially within the UK and European markets.
    • Submitting through MRP, DCP and national procedures.
    • Strong communicator who is able to navigate through difficult conversations with senior stakeholders.
    • Team working skills, able to influence to achieve objectives.

    This position allows for the right candidate to work for a leading generics manufacturer and take charge of UK and European submissions. The role will play a pivotal part in the Regulatory Affairs team and ensure all compliance.

    To apply for this role you must have the full right to work in the EU as this employer does not provide sponsorship. For more information please contact

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