Our biotech client needs a Regulatory PM, ideally with significant experience with getting filings organized and sent out to the FDA. Potential EMA or member nations of Europe submissions but primarily FDA. Supporting one program around an asset they have acquired. Managing timelines and deliverables, version control, working on 1 major IND submission for Q1. Additional work may lift off start of new year. Hoping for reg affairs experience as well. Able to contribute across functions. They have a Reg Ops Consultant doing the version control work but mostly focused on reg cmc work. Once clinical catches up this work will expand. Must be experienced with getting INDs in on time. Should be flexible, not rigid about approach. Should have sharepoint experience, excel, gantt charts, MS Timeline or Project experience preferred, smartsheet experience or similar software is needed. PMP would be nice to have. At least 10 years of experience. Biologics background would be beneficial. Oncology experience a plus. Submissions include INDs and CTAs. Work would consist of planning for FDA interactions (pre-IND meetings, pre- BLA meetings), driving timeline for successful on-time submissions, coordinating communications with the FDA, preparing briefing documents, investigator brochures, developing and submitting INDs. The ideal candidate would be at the associate director level.
regulatory project management, IND, CTA, submissions
N/A, experience outweighs degree.
Remote: Regulatory PM (232208)