Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovation - Small Molecules

Role: Senior Regulatory CMC Lead supporting small molecule drug development and commercialization across multiple modalities, focusing on global regulatory strategies, submission preparation, and lifecycle management. Responsibilities: develop and implement innovative CMC regulatory strategies; provide guidance on global regulations and guidelines; lead preparation and review of regulatory documents for clinical trials, market applications, and post-approval variations; ensure alignment of CMC strategies across geography; proactively address regulatory challenges and maintain compliance. Requirements: B.S. in science or engineering (advanced degree preferred); 10+ years in regulatory CMC supporting clinical development or commercialization of synthetic molecules; strong knowledge of global CMC regulatory landscape, drug substance and drug product development, analytical sciences, and manufacturing. Preferred: experience authoring CMC submissions, participating in Health Authority meetings, risk management, and regulatory initiatives. HighValue: focus on small molecule APIs, regulatory support for phases supporting clinical trials and market registration, experience with synthetic molecules, global regulatory expertise. WorkSetup: Indianapolis, IN, with possible remote option; minimal US travel.