Director, Global Regulatory Lead, GI & Inflammation

Role: Lead global regulatory strategy for complex pharmaceutical projects, ensuring regulatory success and compliance with global agencies, including FDA submissions and approvals. Responsibilities: define and oversee strategic regulatory plans, lead Regulatory Teams (GRTs), manage regulatory submissions, maintain stakeholder communication, and collaborate cross-functionally with regional and external partners, including health authorities and vendors. Provide tactical advice, anticipate regulatory risks, and adapt strategies to evolving global requirements. Lead key interactions with FDA and other agencies, and contribute to cross-departmental initiatives. Requirements: Bachelor's in a scientific discipline; advanced degree (PharmD/PhD/MD) preferred; 8+ years in pharma, with at least 6 years in regulatory affairs or related roles; strong knowledge of drug development, global regulatory processes, and submission management. Preferred: experience in reviewing and authoring regulatory documents, understanding of FDA, EU, and other international regulations, and ability to interpret complex scientific data for regulatory strategy. High-Value: focus on global regulatory leadership, US FDA interactions, complex project oversight, and cross-functional collaboration. Work Setup: hybrid in Boston, MA.