Senior Director, Regulatory Affairs CMC

Madrigal Pharmaceuticals seeks a Senior Director of Regulatory Affairs CMC to lead strategy and execution for chemical manufacturing and controls across clinical, registration, and post-approval stages. The role requires deep expertise in small molecule regulatory development and global health authority interactions.

Responsibilities

• Independently develop and execute regulatory CMC strategies for investigational, registration, and post-approval products
• Apply expert CMC knowledge to resolve development and commercialization challenges
• Guide team in defining CMC dossier content and review for Health Authority compliance
• Represent regulatory CMC function in Health Authority meetings and drive preparation activities
• Identify regulatory CMC risks proactively, develop mitigation strategies, and communicate to management

Requirements

• BS in life sciences or healthcare field; advanced degree strongly preferred
• Minimum 15 years regulatory CMC experience with broad technical and product knowledge
• Proven track record managing small molecule clinical, commercialization, and lifecycle activities
• Demonstrated experience interacting with global Health Authorities on CMC matters
• Strong knowledge of global pharmaceutical CMC regulations, guidelines, and standards
• Excellent written and verbal communication and negotiation skills

Compensation: $258,827–$293,479 per year