Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-11213442
  • Location: Wilson North Carolina (NC) 27893
  • Posted Date: 09/15/2020
  • Duration: 11 Months
Talk to our Recruiter

  Job Description

  • Contributes to the preparation and submission of regulatory filing documents.
  • Monitors and tracks information and requirement changes.

Major Accountabilities:

  • Provides assistance to members of the RA team in the compilation of ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions.
  • Maintains compliance with regulatory requirements for generic drugs for the US market.
  • Reviews ANDA labeling documents
  • Maintains Regulatory Databases
  • Receives general supervision and detailed instruction on new projects
  • This position has no supervisory responsibility.

Key Performance Indicators:

  • Knowledge: Limited use and/or application of technical principles, theories, and concepts.
  • Problem Solving: Develop solutions to routine technical problems of limited scope.

Education:

  • Bachelor’s degree in a scientific related field