Regulatory Affairs Specialist job in Bethesda at Technical Resources International
Technical Resources International

Bethesda, Maryland

This job has expired.


Responsibilities:

  • Prepare, distribute and track Investigational New Drug Applications (INDs)
  • Prepare FDA required IND sponsor's annual reports
  • Prepare scientific and other regulatory documents for submission to the Food and Drug Administration (FDA)
  • Attend scientific meetings and reviews the literature to stay current with new developments in the infections disease field (in particular, human immunodeficiency virus (HIV) and tuberculosis (TB) and therapeutic clinical research
  • Preparation of investigator/pharmaceutical company meeting minutes
  • Perform literature searched and extraction of information to support regulatory documents

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