Associate Director, Regulatory Operations Global Submission Management

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.

Job Title: Associate Director Regulatory Operations Global Submission Mgmt

Location: [Conshohocken, PA/Waltham, MA]

About the Role:

We are looking for an experienced and highly organized Global Submission Associate Director to join our Global Regulatory Affairs team. In this key role, you will lead and manage the planning, compilation, and delivery of high-quality regulatory submissions to health authorities while supporting global initiatives.

You will collaborate closely with cross-functional teams including Regulatory Strategy, CMC, Clinical, Labeling, and vendors to ensure submission excellence and compliance with evolving regulatory requirements.

Key Responsibilities:

• Submission Leadership: Plan, manage, and execute complex regulatory submissions (e.g., IND, NDA, MAA, variations, renewals, responses to questions) for Global markets.
• Global Collaboration: Act as the US regulatory submissions expert within global submission teams, ensuring alignment with global strategies and timelines.
• Agency Interface Support: Support interactions with the FDA, national competent authorities, and Health Authorities during the review process.
• Quality Oversight: Ensure submissions are prepared according to current regulatory standards (eCTD format) and company SOPs.
• Timeline Management: Develop detailed submission plans and track key milestones to ensure on-time delivery of high-quality regulatory dossiers.
• Process Optimization: Contribute to the development and improvement of global submission processes, templates, and best practices.
• Training and Guidance: Provide mentorship and guidance to submission coordinators and junior staff
• Regulatory Intelligence: Monitor and assess changes in regulatory requirements that impact submission strategies and advise relevant teams accordingly.

Qualifications:

• Bachelor’s degree in Life Sciences or a related discipline (advanced degree preferred).
• 8+ years of experience in R&D.
• Solid knowledge of submission processes, procedures, and eCTD format.
• Experience managing major submissions (e.g., INDs, NDA, RFIs).
• Strong understanding of regulatory operations systems (RIMS, EDMS, publishing platforms).
• Demonstrated ability to lead complex projects and cross-functional teams in a global environment.
• Excellent written and verbal communication skills in English
• Detail-oriented with strong organizational and project management skills.

What We Offer:

• A dynamic, international environment with opportunities for growth and development.
• A chance to be part of major product submissions and launches across Europe and globally.
• Competitive salary, annual bonus, and a comprehensive benefits package.
• Flexible working arrangements, including hybrid and remote options.

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