Associate Director, Global Regulatory Affairs Project Management

Role: Associate Director, Global Regulatory Affairs Project Management, supporting late-stage oncology drug development and global regulatory submissions. Responsibilities: manage regulatory submission processes from planning through filing, including INDs, CTAs, NDAs/MAAs; develop and track timelines; coordinate cross-functional teams (Regulatory Science, Clinical, CMC, Medical Writing, etc.); facilitate global regulatory strategies and agency interactions; build dashboards and improve project management tools. Requirements: Bachelor's in life sciences; 12+ years in pharma/biotech, with 6-8+ years in regulatory project management; extensive experience in U.S. drug marketing applications; strong knowledge of global regulations, CTD structure, and cross-functional coordination; proficiency with project management tools (e.g., Smartsheet, MS Project). Preferred: experience supporting global filings including Japan, Canada, EU/UK; oncology drug development background; familiarity with complex oncology trials. HighValue: oncology, late-stage development, global regulatory submissions, cross-functional leadership, project management expertise. WorkSetup: not specified.