Global Regulatory Lead - Immunology

Role: Serve as the Global Regulatory Lead (GRL) responsible for developing and executing global regulatory strategies across the entire product lifecycle, from portfolio entry to end-of-life. Key responsibilities include shaping regulatory pathways, managing US FDA submissions and interactions (INDs, NDAs, BLAs), leading cross-functional teams (including CMC, GRA-Science, and Labeling), and building external stakeholder relationships to influence the regulatory environment. Requirements: Advanced degree (PharmD, PhD) with 8+ years in regulatory affairs or drug development, or Bachelor's/Master's with 10+ years. High-value specifics: deep knowledge of global regulatory processes, experience with US, EU, China, Japan submissions, and expertise in both clinical and CMC regulatory sciences. The role involves strategic leadership, stakeholder communication, risk assessment, and external engagement. Travel expectations are 10–15%. Location options include Indianapolis, IN, or Boston Harborside, with relocation support.