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Regulatory Affairs Specialist at Technical Resources International

Posted in Other 30+ days ago.

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Location: Bethesda, Maryland

Job Description:
  • 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

Job Requirements
  • Scientific background preferred
  • Exposure to GCPs and clinical trials a plus
  • Excellent oral, written and interpersonal skills
  • Ability to analyze medical research data and review experimental protocols
  • Working knowledge of word processing, spreadsheet and database management programs
  • M.S. or Ph.D. or equivalent related experience in pharmacology, toxicology, biochemistry, molecular biology, immunology