Senior Director, Regulatory Affairs CMC

Role: Senior Director of Regulatory Affairs CMC leading strategic and operational oversight of regulatory chemistry, manufacturing, and controls activities for Madrigal's development and commercial products, including Rezdiffra for MASH. Responsibilities: develop and execute CMC regulatory strategies across product lifecycle stages, prepare and review CMC dossiers, represent the company in health authority meetings, and monitor global regulatory requirements. Provide global regulatory support for quality activities and risk mitigation related to CMC. Requirements: BS in life sciences or healthcare; 15+ years in regulatory CMC with broad technical experience, including global interactions and knowledge of pharmaceutical regulations. Preferred: advanced degree. HighValue: expertise in small molecule development, global health authority engagement, CMC dossier content and strategy, and lifecycle management. WorkSetup: hybrid (3 days onsite) based in Waltham, MA or Conshohocken, PA.