Associate Director, Global Regulatory Project Management

Role: Associate Director, Global Regulatory Project Management, leads global regulatory strategies and manages complex submissions (NDAs, BLAs, MAAs) across regions to support drug development and market access. Responsibilities: translate global regulatory plans, oversee cross-functional teams, coordinate international submissions, build stakeholder relationships, and drive process improvements. May supervise or mentor regulatory staff and promote regulatory excellence. Requirements: Bachelor’s in Science or related field; 8+ years in regulatory project management with experience in small molecules and biologics; proven global submission success; strong leadership, strategic thinking, and communication skills. High-Value: global scope, multi-region regulatory submissions, biologics and small molecules, development lifecycle (IND/CTA to post-market), cross-functional collaboration (clinical, CMC, safety, commercial), proficiency with project and document management tools (e.g., Smartsheets, MS Project, Power BI). Work setup: not specified; occasional international travel possible.