Director, Regulatory Affairs CMC

Role: Lead regulatory CMC strategist for Madrigal's biopharma development and commercial products, primarily focused on small molecule therapeutics for metabolic liver disease. Responsibilities: develop and execute global CMC regulatory strategies for investigational, registration, and post-approval phases; guide CMC dossier content to meet health authority requirements; represent the company in regulatory meetings; support quality-related regulatory activities, including impact assessments for changes and investigations; identify and communicate CMC risks proactively; monitor evolving global regulatory guidelines. Requirements: BS in life sciences or related field; minimum 12 years of relevant experience with 8-10 years in regulatory CMC, particularly for small molecules; proven experience managing CMC regulatory strategies across clinical and commercial lifecycle; strong knowledge of global regulations and guidelines; experience engaging with health authorities; excellent communication and negotiation skills. HighValue: Expertise in CMC development for small molecule drugs, including clinical and commercialization phases; global regulatory interactions; post-approval and lifecycle management; strong understanding of GxP and quality standards. WorkSetup: Not specified, but likely hybrid or onsite given senior regulatory leadership role.