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Regulatory Affairs Specialist

Company: Beacon Hill Staffing Group - Pharma
Location: Worcester
Posted on: June 14, 2019

Job Description:

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

Keywords: Beacon Hill Staffing Group - Pharma, Worcester , Regulatory Affairs Specialist, Other , Worcester, Massachusetts

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