Director, Regulatory Affairs CMC

Overview

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH). This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post‑approval submissions, and manages day‑to‑day regulatory CMC activities for assigned projects.

• Independently develop and lead execution of regulatory CMC investigational, registration and/or post‑approval strategies for assigned products.
• Apply expert regulatory CMC knowledge to address and overcome challenges during development and commercialization.
• Guide the team in defining and driving the strategy for CMC regulatory dossier content and review this content for conformance with Health Authority requirements.
• Represent the Madrigal Regulatory CMC function in Health Authority meetings and drive preparation activities for those meetings.
• Provide global regulatory input and support to quality‑related activities, including impact assessments for change controls, deviations and investigations.
• Proactively identify regulatory CMC risks and communicate timely with line management.
• Monitor, interpret and communicate relevant global regulatory requirements, guidelines and emerging trends.

• BS in life sciences in a healthcare field or equivalent experience; advanced degree strongly preferred.
• Minimum of 12 years relevant experience, including 8‑10 years regulatory CMC experience, with broad‑based CMC technical and product experience.
• Strategic regulatory CMC experience with a proven track record in clinical, commercialization and life‑cycle management of small‑molecule products.
• Demonstrated experience interacting with global Health Authorities on CMC topics.
• Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals.
• Excellent communication and negotiation skills, able to effectively communicate with technical SMEs and present scientific cases to stakeholders and regulatory agencies.

• Competitive base salary (US $207,000–$253,000 per year) and bonus.
• Equity participation for all employees.
• Comprehensive benefits including flexible paid time off, medical, dental, vision and life/disability insurance.
• 401(k) plans (traditional, Roth, employer match).
• Additional voluntary benefits such as supplemental life insurance and legal services.
• Mental health benefits through Employee Assistance Program.

All full‑time employees are eligible for reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact .

Equal Opportunity Employer. Employment is decided on the basis of qualifications, merit, and business need, with consideration given without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran status or other characteristic protected by applicable federal or state law.