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GMP/GDP Regulatory and Risk Management

Edison-New Brunswick Metro Area, NJ

Post Date: 07/10/2018 Job ID: JN -072018-22010 Job Type: Scientific
  • This position is responsible for managing and administering the Emerging/Changing Regulation Process.
  • 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 follow up and ensure that impacted documentation is updated within the established timeframe.
    - 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.
  • 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.

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