Director, Global Submission Management

Role: Director of Global Submission Management overseeing global regulatory submissions throughout development and lifecycle stages, ensuring timely, compliant delivery aligned with global strategies. Responsibilities: develop and manage submission plans, coordinate cross-functional activities with Regulatory Strategy, CMC, Labeling, and Publishing teams, oversee submission quality and compliance, mitigate operational risks, and lead staff and vendor teams. Qualifications: Bachelor's in Life Sciences, 10+ years in regulatory submission management, proven leadership in managing routine, regional, and lifecycle submissions across multiple regions, experience with project management tools (e.g., MS Project, Veeva RIM). High-Value: expertise in global regulatory requirements, GxP, and emerging technologies including AI; experience with development-stage biologics or small molecules preferred. Work setup: hybrid or on-site, with flexible arrangements.