Global Regulatory Lead - Immunology

Role: Global Regulatory Lead (GRL) responsible for developing and executing comprehensive global regulatory strategies across product lifecycle stages. Key responsibilities include leading regulatory strategy development, managing US FDA submissions and interactions (INDs, NDAs, BLAs), and guiding a cross-functional Regulatory Team (including CMC, R&D, Labeling). The GRL serves as the primary regulatory authority on the Global Brand Development team and liaises with external stakeholders to shape the regulatory environment. Requirements: Advanced degree (PharmD, PhD) with 8+ years in regulatory affairs/drug development or Bachelor’s/Master’s with 10+ years, with deep knowledge of global regulatory procedures, evolving reforms, and experience with US, EU, China, and Japan agencies. Preferred skills include leadership, stakeholder communication, risk management, and experience in clinical and CMC sciences within relevant therapeutic areas. High-value specifics: focus on pharmaceutical development, global regulatory strategy, US FDA engagement, cross-functional leadership, and international regulatory experience. Work setup: Based in Indianapolis, IN, with potential for Boston, MA; travel expected 10–15%.