Senior Director, Regulatory Affairs CMC

Socket.dev; Pennsylvania; Hybrid; USD 259,000 - 293,000; Full time

Benefits offered by this job

Equity

Hybrid work model

Comprehensive benefits

401(k) options

Job summary

Madrigal is seeking a Senior Director of Regulatory Affairs CMC to lead regulatory CMC strategy across development and post‑approval lifecycle in a high‑paced biopharma setting. You will guide cross‑functional teams, write and review CMC content, and liaise with global authorities to ensure compliant and timely submissions.

In this hybrid role based in the US, you will monitor evolving regulations, manage risk, and support inspections while coordinating with quality and development teams to

Qualifications

• BS in life sciences in a healthcare field or equivalent experience; advanced degree strongly preferred.
• Minimum 15 years’ regulatory CMC experience with broad CMC knowledge and product exposure.
• Strategic CMC leadership with record in clinical, commercialization and lifecycle management.
• Experience interacting with global Health Authorities on CMC topics.
• Excellent communication and negotiation skills; able to present science to diverse audiences.
• Hybrid work arrangement with in-office presence required in MA or PA.

Responsibilities

• Develop and lead execution of regulatory CMC strategies for development and post‑approval lifecycle.
• Apply CMC knowledge to address challenges during development and commercialization.
• Define and drive dossier content strategy; write/review content per Health Authority requirements.
• Represent CMC in Health Authority meetings and prepare for discussions on CMC topics.
• Provide global regulatory input to quality activities; support inspections and change controls.
• Identify CMC regulatory risks and communicate mitigations with management.
• Monitor evolving CMC regulatory requirements and emerging trends.

Skills

Regulatory CMC strategy

Global regulatory interactions

Regulatory submissions

Cross-functional leadership

Negotiation skills

Regulatory intelligence

Education

BS in life sciences or healthcare field

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.