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Tadworth

    Regulatory Manager - Tadworth, United Kingdom - Pfizer

    Pfizer
    Pfizer Tadworth, United Kingdom

    3 weeks ago

    Default job background
    Scientific
    Description

    JOB OVERVIEW


    This position offers a great career growth opportunity as an individual contributor with potential for managing a team in the future. The role involves strategic planning, taking initiative, and handling various projects. Below are the details of the responsibilities:


    • Lead, motivate, and develop direct reports
    • Manage projects and strategies at a departmental level
    • Supervise permanent staff and contractors
    • Contribute to regulatory input for product teams
    • Oversee Clinical Trial Authorizations and Marketing Authorizations
    • Maintain compliance with statutory tasks
    • Provide regulatory advice to key customers

    Location:

    Walton Oaks, Surrey or Watermarque, Dublin (Flexible)


    RESPONSIBILITIES


    Department & Project Management:
    • Identify and manage key Regulatory Department projects
    • Ensure efficient processes within the department
    • Participate in cross-functional project teams
    • Monitor regulatory activities and timelines

    People and Resource Management:
    • Manage performance and development of direct reports
    • Provide coaching and guidance to regulatory team members
    • Ensure manageable workloads and effective team performance

    Contribute to Cross-functional Teams and Build Regulatory Expertise:
    • Develop optimal regulatory strategies
    • Represent Regulatory on product teams
    • Provide regulatory input to strategic planning
    • Improve alignment of regulatory strategies
    • Provide advice on regulatory matters

    Submit Marketing Authorization Applications:
    • Review and approve necessary technical data
    • Prepare and submit documentation for regulatory approvals

    Manage and Submit MA Variation Applications:
    • Prepare required documents and ensure compliance
    • Coordinate variation submissions

    Manage and Submit MA Renewal Applications:
    • Prepare renewal documents and review supporting data

    ... (Text truncated)


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