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. Key Responsibilities 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 Minimum Qualifications 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 Additional Preferences 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 Additional Information Travel: 10–15% Indianapolis, IN; relocation provided Benefits 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. #J-18808-Ljbffr Scorpion Therapeutics