Regulatory Project Manager
10770 Wateridge Circle , Suite 210 San Diego, CA 92121 US
Job Description
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
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About San Diego, CA
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.