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
