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Regulatory Affairs Professional CMC - Oferta z Jobs.pl

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Regulatory Affairs Professional CMC

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  • Our client a leading pharmaceutical manufacturing company now have an immediate requirement for a Regulatory Affairs Professional- CMC. This is a full time 15 month fixed term contract based in Dublin.

    Applicants should have a strong knowledge and experience of working with quality documentation for drug products and drug substances.

    As Regulatory Affairs Professional you will be working with development and maintenance/ of the CMC documentation for the Company's products (Drug Substances and Drug Products).

    You will perform regulatory assessment of change control cases. You will prepare regulatory strategies and participate in the preparation of the quality documentation to support clinical trial applications (INDs, IMPDs), new marketing authorisations (NDAs, MAAs) and variation applications in global markets.

    In close cooperation with other Regulatory Affairs colleagues, you will plan and project-manage CMC related aspects regarding submissions. You will be part of a cross-functional team, which has the responsibility to create and maintain CMC documentation for drug substances and drug products. You will participate in and provide regulatory support to project teams looking into development and life-cycle management of the products.

    Experience & Qualifications
    • Relevant scientific degree
    • 2-3 years' experience from Regulatory Affairs within CMC development or life-cycle management
    • Knowledge of regulatory requirements in EU, US - preferably also in countries outside EU, e.g. Japan
    • Clear focus on agreed objectives, even when working with tight deadlines.

    For more information and to apply for this role please call Linda on 1 or e-mail

    Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1


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