Senior Director, Regulatory CMC Strategy

Madrigal; United States; On-site; USD 207,000 - 253,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

401(k) with employer match

Flexible PTO

Job summary

Madrigal is a biopharmaceutical company focused on advancing therapies for MASH. We seek a senior regulatory CMC leader to guide strategy across development and lifecycle management for small molecule products.

This role interfaces with global health authorities and cross-functional teams to ensure compliant, efficient submissions. As part of Madrigal’s Total Rewards, you’ll receive equity, comprehensive benefits, and a strong compensation package.

Qualifications

• BS in life sciences or equivalent; advanced degree strongly preferred.
• Minimum of 12 years relevant experience with 8–10 years regulatory CMC experience.
• Strategic regulatory CMC experience with track record in clinical, commercialization and lifecycle management.

Responsibilities

• Independently develops and leads execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
• Applies expert regulatory CMC knowledge to address challenges during development and commercialization.
• Guides the team in defining and driving the strategy for CMC regulatory dossier content and reviews content for Health Authority conformance.
• Represents the Madrigal Regulatory CMC function in Health Authority meetings and drives preparation activities for meetings on CMC topics.
• Provides global regulatory input and support to quality-related activities, including regulatory impact assessments for change controls, deviations and investigations.
• Proactively identifies regulatory CMC risks, ensuring timely communication with line management.
• Monitors, interprets and communicates relevant CMC-related global regulatory requirements, guidelines and trends.

Skills

Regulatory CMC knowledge

Strategic regulatory thinking

Communication skills

Negotiation skills

Presentation to SMEs

Education

BS in life sciences (healthcare) or equivalent

Job description

Madrigal is a biopharmaceutical company focused on advancing therapies for MASH. We seek a senior regulatory CMC leader to guide strategy across development and lifecycle management for small molecule products.

This role interfaces with global health authorities and cross-functional teams to ensure compliant, efficient submissions. As part of Madrigal’s Total Rewards, you’ll receive equity, comprehensive benefits, and a strong compensation package.