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Regulatory Affairs Consultant

Location: Lawrence Township, New Jersey , US, 08648

Summary:

Actively contribute to the development and implementation of regulatory strategy for assigned projects.

Project Details:

  • Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, NDAs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival)
  • Provide thoughtful & accurate comments during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, mindful of regulatory/ICH guidance/requirements pertaining to document content
  • Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions
  • Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings
  • Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.)
  • Monitor company progress toward fulfillment of regulatory commitments
  • Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments
  • Review and communicate current & emerging regulatory requirements (e.g., US and international regulations and guidelines)
  • Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts
  • Develop and maintain current regulatory knowledge
  • Handle multiple projects and exercise good judgment in prioritizing tasks

Job Experience:

  • 5 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility
  • Experience working with innovator products and designing and executing creative development strategies are highly desirable
  • Must have a solid understanding of FDA regulations and ICH guidance's, as well as a comprehensive knowledge of the drug development process
  • Experience with regulatory submissions, including INDs, NDAs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential

Hourly Rate: 56.1-72.6

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