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Regulatory Information Specialist

This Direct-Hire position is in the Food and Drug Administration, the Center for Biologics Evaluation Research, located in Silver Spring, MD.

Responsibilities

  • Compile computerized regulatory information/data pertaining to assigned products.
  • Assist in coordinating and/or providing both periodic and special reports pertaining to product review status activities.
  • Manage assigned areas of the regulatory information system that supports products submissions and licenses regulated by the Division.
  • Assist team in identifying where information for the assigned areas may impact other data found in multiple parts of the assigned database systems and how those data need to interact.
  • Responsible for the overall integrity and accuracy of information and data in assigned aspects of the system