Role:
Global Regulatory Lead (GRL) responsible for developing and executing global regulatory strategies throughout product lifecycle, providing strategic and technical leadership to a cross-functional team, and managing US FDA interactions.
Responsibilities:
shape regulatory strategies for development, approval, and post-market phases; oversee US FDA submissions (INDs, NDAs, BLAs), ensure regulatory plans align globally and locally, and represent regulatory interests in cross-functional teams; build external stakeholder relationships.
Requirements:
Bachelor's degree with 8+ years in regulatory affairs or drug development; advanced scientific degree preferred.
High-Value:experience with global regulatory procedures, regulatory submissions across US, EU, China, Japan; knowledge of clinical and CMC regulatory sciences; strong leadership and stakeholder communication skills; therapeutic area experience preferred.
WorkSetup:based in Indianapolis, IN; travel 10-15%.
