Director, Regulatory Affairs CMC

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. Key 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 and overcome challenges that arise during development and commercialization. Guides the team in defining and driving the strategy for CMC regulatory dossier content and then reviews this content for conformance with established Health Authority requirements. Represents the Madrigal Regulatory CMC function in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC-related 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 emerging trends. Required & Desired Qualifications BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred. Minimum of 12 years relevant experience and 8-10 years’ regulatory CMC experience, along 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 is required. Excellent communication skills and proven negotiation skills. Must be able to effectively communicate with technical SMEs at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies. Total Rewards and Benefits Madrigal offers a competitive total rewards package that includes base salary, bonus, and equity. Equity is provided to all full‑time employees, reinforcing an ownership culture and allowing staff to share in the company’s success. Base salary ranges from $207,000 to $253,000 per year, and is determined by qualifications, skills, education, experience, business needs, and market demand. We also provide comprehensive benefits, including flexible paid time off, medical, dental, vision, and life/disability insurance, a 401(k) plan with employer match, and additional voluntary benefits such as supplemental life insurance, legal services, and mental health support. Reasonable Accommodations We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact View email address on click.appcast.io. EEO Statement Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. #J-18808-Ljbffr