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Regulatory Submissions Management Professional - Oferta z Jobs.pl

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Regulatory Submissions Management Professional

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  • Our client, a pharmaceutical company based in Dublin are now actively recruiting for a Regulatory Submissions Management Professional. This is a senior post within the organisation. It is permanent and based in Dublin.

    The primary focus of the Submission Management Professional is to manage and facilitate the delivery of submissions within a given product/asset. This position is the overall accountable and responsible for project managing individual submissions under an asset.
    the Submissions Management Professional is responsible for monitoring progress performance via the project plans and/or eCTD tracker and for securing deliverable for the individual submissions.

    Key Aspects of the Role Include:

    • Responsible for preparing the Regulatory Submissions Pipeline
    • Responsible for verifying and sending project request to Company's sourcing partner

    • Responsible for preparation of submissions
    • Responsible for liaising with RA content owners and relevant contributing functions to secure relevant documents and submission components for the dossier

    • Responsible for coordinating review of published output with contributing functions

    • Responsible for ensuring that the dossier is submitted to the HA Proactively

    Experience & Qualifications

    • Scientific Master degree, bachelor degree or similar work experience
    • Preferably training/courses within Regulatory Affairs and project management
    • Typically some years of experience working within Regulatory Affairs
    • Understanding of CMC and Labelling components for post-approval activities
    • Knowledge and preferably experience within Submission Management in relation to submission processes

    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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