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    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

    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.

    Responsibilities of the role:

    • Advising the GRT on regional considerations in developing strategy
    • Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
    • May manage one or more regional leads or support roles
    • May 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.
    • Review and approve materials for use in the EU.
    • Strategy and Execution Plans and manage regulatory submissions.
    • Implement product related regulatory strategies, Regulatory Affairs processes and activity planning.
    • Manage in the development of the regional product label with the Labelling Working Group.
    • Supports regional label negotiation activities, participate in the development and execution of regional regulatory product strategies.

    Requirements:

    • Working with policies, procedures and SOPs
    • Knowledge of relevant legislation and regulations relating to medicinal products
    • Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
    • Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and international borders.

    Interested candidates should submit an updated CV.

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