Remote Senior Regulatory Affairs Manager

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Mon, May 16, 2022
Job Summary

A clinical research firm has a current position open for a Remote Senior Regulatory Affairs Manager.

Candidates will be responsible for the following:

  • Preparing submissions and oversee the maintenance of regulatory filings to support multinational trials
  • Reviewing clinical trial documents including clinical protocols/reports, investigator brochures and, nonclinical reports
  • Serving as Regulatory representative on project teams

Qualifications for this position include:

  • Able to lead the preparation of submissions, which may include INDs, CTAs, and briefing documents
  • Comfortable liaising with regulatory agency project manager in coordinating meetings
  • Ability to manage regulatory timelines, and provide strategic input
COMPLETE JOB DESCRIPTION

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