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Uxbridge

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

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    Description
    PE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract.

    Advising the GRT on regional considerations in developing strategyEnsuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholdersMay manage one or more regional leads or support rolesMay participate as a member of:

    Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g.

    IMT, IBT, NAMT)Act as a contact with relevant regulatory agencies in fulfilling local obligations.
    Under general supervision participates in core regulatory activities to ensure effective regional agency interactions.
    Strategy and Execution Plans and manage regulatory submissions.
    Implement product related regulatory strategies, Regulatory Affairs processes and activity planning.
    Supports regional label negotiation activities, participate in the development and execution of regional regulatory product strategies.


    Requirements:

    Working with policies, procedures and SOPsKnowledge of relevant legislation and regulations relating to medicinal productsAwareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.



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