Director, Regulatory Affairs CMC

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 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.

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.

Madrigal’s Total Rewards strategy & Compensation

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $207,000 - $253,000 per year. We comply with all applicable minimum wage laws.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.

• Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
• We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings.
• In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.
• The company also provides other benefits in accordance with applicable federal, state, and local laws.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

If you need assistance, please contact [e-mail].

Commitment to Equal Opportunity & Diversity

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.

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.

Join our growing team focused on transforming the treatment of people with liver diseases.