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Director of Regulatory Affairs

Company: Parker and Lynch
Location: Morristown
Posted on: June 20, 2022

Job Description:

We are working with the VP of Regulatory Affairs at a Pharmaceutical company ($1B in revenue), based in Morris County, NJ. They are looking for a dynamic Regulatory Affairs Director to join their team.RESPONSIBILITIES:

  • Lead regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA including ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files.
  • Participates in the establishment of project plan due dates and ensure that the due dates for milestones are met.
  • Assists in promoting sound strategies in support of submission goals.QUALIFICATIONS:
    • 10+ years in Pharma/ Bio tech industry with at least 6 years in Regulatory Affairs.
    • Life Science Bachelor Degree Highly Preferred
    • Generics Industry Experience Preferred

Keywords: Parker and Lynch, Newark , Director of Regulatory Affairs, Executive , Morristown, New Jersey

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