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Regulatory Affairs Specialist


  • Beacon Hill Staffing Group - Pharma
  • 08/06/20
  • Boston, MA
  • 02114
  • Full-Time
Manages and provides supports with the planning and execution of high quality regulatory submissions for assigned products, including both pre-approval and post marketing submissions. This includes regulatory submissions (NDAs, BLAs, MAAs, INDs, and supplmentals) and other US submissions including amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates etc., consistent with US regulatory requirements. Responsible for drafting and preparation of forms and cover letters required for US Submissions.
Knowledge of FDA regulations and guidelines on drug development and the approval process for NDA/BLA and postmarketing supplements
Understanding of US and EU requirements


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