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Regulatory Affairs Associate



Regulatory Affairs Associate
Kansas City, Missouri
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Regulatory Affairs Associate – Kansas City, MO

  • Prepares, compiles, reviews, and finalizes regulatory applications for submissions of original ANDAs, supplements, deficiency responses/amendments, and Annual Reports
  • Prepares, reviews, and validates XML files to execute electronic submissions to the FDA
  • Creates, revises and reviews labeling per current FDA requirements
  • Tracks, renews, and completes new state licensing applications based upon requirements of each state
  • Interacts with other functional department to coordinate and facilitate quality and timely submissions
  • May represent Regulatory Affairs at designated meetings
  • Maintains electronic and physical files of all documents received and generated by the Regulatory Department
  • Maintains tracking of various filings and other distinct regulatory reports to ensure workflow through the department and satisfactorily meeting external and internal deadlines
  • Comprehends current knowledge base & keeps abreast of new regulations, standards, or guidance documents
  • Performs other duties as assigned


  • Bachelor’s Degree with emphasis on Pharmaceutical, Chemistry, Biologic Science, or a related field
  • 2 years related experience required.
  • Electronic filing experience
  • Proficient in Microsoft Excel, Word. Rosetta, Gecco, and Fixmd5 preferred
  • Excellent detail orientation and analytical skills
  • Excellent communication skills and presentation skills
  • Strong discretion of confidential matters and overall business ethics

Job Type: Contract to Hire
Shift: M-F 8a-5p
Pay Rate: 50-53K

For Immediate Consideration, Apply Today! For more information contact Toni at 714 454 8252 / [email protected], or schedule a time to connect @



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