Senior Director, Regulatory CMC Strategy (Hybrid)

Madrigal Pharmaceuticals; Waltham (MA); Hybrid; USD 259,000 - 293,000; Full time

Job summary

Madrigal Pharmaceuticals, a biopharmaceutical company focused on advancing therapies for metabolic dysfunction-associated steatohepatitis, is seeking a Senior Director of Regulatory Affairs CMC to provide strategic regulatory leadership for development, registration and post-approval submissions.

You will lead global CMC strategies, write/review dossier content for Health Authorities, and mentor cross-functional teams to anticipate and mitigate regulatory risks, ensuring compliance across

Qualifications

• BS in life sciences or healthcare field; advanced degree preferred.
• Minimum 15 years regulatory CMC experience across development and lifecycle.
• Proven track record with small molecule products and global Health Authorities.
• Strong regulatory knowledge and guidelines for global CMC development.
• Excellent communication and negotiation with SMEs and authorities.

Responsibilities

• Develop and lead execution of regulatory CMC strategies for products in the investigational, registration and/or post-approval lifecycle.
• Address challenges during development and commercialization.
• Guide content for CMC dossiers and ensure regulatory conformance.
• Represent CMC in Health Authority meetings and drive preparation activities.
• Provide input to quality-related activities and regulatory impact assessments.
• Identify CMC risks and mitigation strategies.
• Monitor evolving global CMC requirements and communicate implications.

Skills

Communication skills

Negotiation skills

Health Authority liaison

Regulatory CMC expertise

Strategic thinking

Cross-functional collaboration

Education

BS in life sciences; advanced degree preferred

Job description

Madrigal Pharmaceuticals, a biopharmaceutical company focused on advancing therapies for metabolic dysfunction-associated steatohepatitis, is seeking a Senior Director of Regulatory Affairs CMC to provide strategic regulatory leadership for development, registration and post-approval submissions.

You will lead global CMC strategies, write/review dossier content for Health Authorities, and mentor cross-functional teams to anticipate and mitigate regulatory risks, ensuring compliance across