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Uxbridge

    Regulatory Affairs Manager - Uxbridge, Greater London, United Kingdom - PE Global

    PE Global
    PE Global Uxbridge, Greater London, United Kingdom

    2 weeks ago

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    Description

    Job Description PE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract.

    Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products.

    Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
    Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
    Provides guidance for regulatory assessments of change control requests
    Sets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; Gathering, consolidating and analyzing regulatory intelligence for International Markets and supports its application to product-specific activities
    Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
    Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products.
    Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.

    An extended knowledge of UK regulatory affairs.
    Previous experience within a regulatory affairs environment.
    CMC regulatory affairs experience.
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