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Senior Regulatory Affairs Manager - Oferta z Jobs.pl

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Senior Regulatory Affairs Manager

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  • Regulatory Professionals are now working with a leading Pharmaceutical consultancy to recruit a Senior Regulatory Affairs Manager to join there Regulatory team based in the Frankfurt area.

    Job Title: Senior Regulatory Affairs Manager
    Salary: up to €80,000 per annum
    Location: Frankfurt
    Start date: ASAP
    Job Reference: J22742

    Regulatory Professionals are currently looking to support a leading Pharmaceutical Consultancy with recruitment into there Regulatory Affairs team. The successful candidate will be working on project leadership involving European approval procedures and life cycle management. This role will be quite varied so requires candidates who are able to work in a complex environment and adapt to change well. You will be part of a team of around 20, working in a fast paced environment and liaising with colleagues and clients globally. It is important to be able to communicate effectively and be client facing when required. Please note this role is open to both German and English speaking candidates.

    Your tasks:

    ? Planning and implementation of submission procedures (MRP, DCP, CP and national procedures) and Life Cycle process (Variations, renewals, among others).
    ? Working with the project team and communicating effectively with partners and local authorities representatives
    ? Understanding Clinical Trail Applications (CTA and Ethics Committee) - national and international
    ? Reviewing product labelling

    Your profile:

    ? You have successfully completed a degree in pharmacy, medicine or other life sciences
    ?Minimum of 5 years experience focusing on the EU and ideally have experience with launch management (EN), Labelling Management, Clinical Trail Applications (CTA) and with authorization procedures in non-EU countries
    ? Must have a sound knowledge of current pharmaceutical legislation and regulatory requirements (EU)
    ? Experience in project management, are capable of multitasking
    ? Must be a team player, communicative, conscientious, accurate and responsible
    ? MS Excel and Word skills

    If this role is of interest and you would like to apply please do so with an updated version of your CV. If you have any questions please contact me directly on


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