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Senior Associate, Regulatory Affairs

Company: The Judge Group
Location: Morristown
Posted on: November 26, 2022

Job Description:

Location: Morristown, NJ Description: Our client is currently seeking a Senior Associate, Regulatory Affairs This job will have the following responsibilities:

  • Oversee and manage assembly and publishing of all documents while maintaining adherence to FDA standards and internal requirements
  • Interacts effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions, ensuring that departmental timelines are met.
  • Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.
  • Reviews technical documents for accuracy and acceptability for use in new ANDAs, NDAs, Amendments, Supplements, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
  • Independently authors, compiles, reviews and submit high-quality, more complex, original new ANDAs, NDAs, Amendments, Supplements and Annual Reports.
  • Review Modules in eCTD and verify proper hypertext linking and ensure navigational tools are functional
  • Reviews and signs-off on change control documentation. Assesses changes and their impact to the business based on an advanced understanding of regulatory guidelines and applicable federal laws.
  • Assists in formulating sound strategies in support of submission goals. Qualifications & Requirements:
    • Minimum of a Bachelor's Degree in a life science. Advanced degree preferred.
    • Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs. Contact: This job and many more are available through The Judge Group. Find us on the web at

Keywords: The Judge Group, Newark , Senior Associate, Regulatory Affairs, Other , Morristown, New Jersey

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