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Regulatory Project Manager

San Diego, CA 92121

Posted: 03/08/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 546521 Is job remote?: Yes Country: United States

Job Description

Target Pay Rate: 80-106/hr **salary will be commensurate with experience 

Job Summary:
  • RPM experience with IND, CTA filings  
    • Implement planning and timelines, submission and filings of INDs  
    • Planning for FDA interactions (pre-IND meetings, pre-BLA meetings)  
    • Drive timeline adherence for successful on-time submissions  
  • Reg affairs experience  
    • Developing and submitting INDs  
    • Coordinating communications with FDA  
    • Preparing briefing documents, investigator brochures  
  • Soft Skills 
    • Great communicator, collaborative, facilitates team building
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