Senior Director, Regulatory Affairs CMC

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

Benefits offered by this job

Equity in rewards

Flexible paid time off

Medical, dental, vision insurance

401(k) with employer match

Employee Assistance Program

Mental health benefits

Job summary

Madrigal is seeking a Senior Director of Regulatory Affairs CMC to lead regulatory CMC strategy for development and commercial products, including submissions and post-approval activities. You will chair cross-functional teams and interface with Health Authorities.

The role requires at least 15 years of regulatory CMC experience, strong communication and negotiation skills, and a hybrid in-office schedule in Waltham, MA or Conshohocken, PA.

Qualifications

• BS in life sciences in a healthcare field or equivalent experience; advanced degree strongly preferred.
• Minimum 15 years’ regulatory CMC experience with broad-based CMC technical and product experience.
• Strategic regulatory CMC experience with a track record in clinical, commercialization and lifecycle management of small molecule products.
• 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 present scientific cases to SMEs and regulators.
• Hybrid opportunity (3 days per week in office) based in our Waltham, MA or Conshohocken, PA offices.

Responsibilities

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

Skills

Regulatory strategy

Cross-functional collaboration

Communication skills

Negotiation skills

Global Health Authority interaction

Education

Bachelor's degree in life sciences

Advanced degree preferred

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. 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.

The Senior Director of Regulatory Affairs CMC provides highly 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. These activities include acting as a regulatory CMC representative on cross-functions teams, planning regulatory CMC submission strategies, and conducting regulatory CMC intelligence activities.

Key Responsibilities

• Independently develops and leads execution of regulatory CMC strategies for products in the investigational, registration and/or post-approval lifecycle.
• 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 writes and/or 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 inspections and regulatory impact assessments for change controls, deviations and investigations.
• Proactively identifies regulatory CMC risks and develops mitigation strategies, 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 15 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 is required.
• 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
• Hybrid opportunity (3 days per week in office required) based in our Waltham, MA or Conshohocken, PA offices.

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 $258,827- $293,479 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. 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.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [e-mail].

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.

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.