Director, Regulatory Affairs - US Filing Lead

Role: Lead Regulatory Affairs for late-stage oncology programs, focusing on US NDA/MAA submissions. Responsibilities include developing and executing regulatory strategies, coordinating cross-functional teams (Clinical, CMC, Quality, Translational Medicine, Commercial), managing dossier preparation, and leading interactions with Health Authorities. The position involves oversight of regulatory timelines, risk mitigation, and supporting global filing plans, with a focus on accelerated pathways for oncology drug approvals. Requirements: Bachelor's degree in life sciences, pharmacy, or medicine; 12+ years in pharma/biotech, with 8+ years in Regulatory Affairs and significant experience in US NDA filings, oncology drug development, and global Phase 3 studies. Proven success in regulatory submissions, Health Authority negotiations, and managing complex dossiers is essential. Preferred: Advanced degree. High-Value: Oncology, late-stage development, US NDA/MAA, regulatory strategy, global Phase 3 oversight, expedited pathways, cross-functional leadership. Work setup: Onsite in Redwood City, CA, with a salary range of $211,000-$264,000, plus benefits.