Global Regulatory Lead - Immunology

About The Role

As the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies—from portfolio entry through end of life. You will provide strategic and technical leadership to a cross-functional Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.

• Develop and execute innovative global regulatory strategies; own the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle
• Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice
• Lead regulatory representation on the GBD/global program team; shape development plans and solve regulatory barriers
• Ensure local affiliate regulatory plans align to global strategy (labeling, risk management, issues management)
• Oversee US FDA submissions and interactions (INDs, NDAs, BLAs)
• Drive high-quality communications with FDA; build productive FDA relationships
• Provide strategic direction to a cross-functional Global Regulatory Team (regional scientists, CMC, Devices, RD&E, Global Labeling)
• Foster transparent communication and continuous development; communicate key information for execution
• Represent GRA at stakeholder/governance meetings; mentor personnel
• Shape external regulatory environment via strategic stakeholder relationships
• Partner with Regulatory Product Communications and Global Marketing on promotional strategy and press/IR materials

• Advanced scientific degree (PharmD/PhD) and 8+ years in regulatory affairs and/or drug development
• OR
• Bachelor’s or Master’s and 10+ years in regulatory affairs and/or drug development

• Global regulatory knowledge; reform initiatives; integrated drug development process
• Submissions/agency interactions across US, EU, China, Japan; clinical and CMC regulatory experience
• Leadership, negotiation, and stakeholder communication (executive-level); risk assessment/management
• Experience in applicable therapeutic area

• Travel: 10–15%
• Indianapolis, IN; relocation provided

• Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.