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Regulatory Affairs Specialist

Company: Technical Resources International
Location: Bethesda
Posted on: November 20, 2022

Job Description:

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 infectious 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. 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, or immunology.

Keywords: Technical Resources International, Bethesda , Regulatory Affairs Specialist, Other , Bethesda, Maryland

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