Feb 06, 2026
Biogen
About This Role As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen's small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment. What You'll Do The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of regulatory CMC activities across assigned projects and products. Primary duties include: Lead cross-functional teams responsible for global RegCMC submissions (IND/IMPD/CTAs, NDAs/MAAs) and responses to Health Authority...
Professional Diversity Network
Durham, NC, USA
Full-Time
