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GDP/GMP Emerging Regulations Specialist

Newark Metro Area, NJ

Post Date: 05/17/2018 Job ID: JN -052018-21622 Job Type: Scientific
  • Regulatory - GMP / GDP Compliance - Emerging and Changing Regulations Specialist
  • This position is responsible for managing and administering the Emerging/Changing Regulation Process.

    REQUIREMENTS:
    Must have expert GMP/GDP, Quality, and in-depth risk management knowledge at a global level;
    Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy;
    Ability to complete routine tasks with no supervision; Confident in making non-routine decisions in their subject matter area; Able to work proactively. Drives continuous improvement and improves efficiency and productivity within the group or project;
    Skilled at getting resources and information from internal and external contacts.
    The candidate will be responsible for managing the Global Emerging and Changing GMP/GDP Regulation and Guidance process.
    - Required experience with monitoring emerging and changing GMP/GDP regulations and guidance documents on a global level.
    - Ability to coordinate change evaluations and comments.
    - Must have the ability to manage evaluation and comment documentation.
    - Must have the ability to consolidate, write, and publish reports (experienced technical writer).
    - Required experience with monitoring and gaining regulatory intelligence including external observation trends.

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