Senior Manager, Regulatory Strategy

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.

Key Responsibilities

• Works on day-to-day regulatory activities of assigned projects for compounds under development and/or marketed. These activities include supporting the Global Regulatory Lead and acting as a regulatory representative on cross-functional teams, planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities.
   
• Actively participates in the development, creation, and implementation of regulatory and development products by providing regulatory guidance and compliance oversight for regulated products.
• Works collaboratively with regulatory leadership in the development of draft labeling for drug development candidates.  Participates on cross-functional teams to establish regulatory strategy for developing content for draft package inserts for NDA/BLA submissions.
   
• Interfaces with various departments within R&D, Commercial and other applicable groups to develop and execute viable Regulatory Strategies in collaboration with the Global Regulatory Lead. Develop partnerships both internal and external to the company.  Accurately assess and convey regulatory risk/opportunities and influence decision makers. 
• Responsible for working on the compilation, submission and maintenance of INDs, NDAs, MAAs, CTAs, labeling submissions, amendments, and supplements. 
• May serve as a Company contact with FDA.
• In collaboration with the Global Regulatory Lead aids in the preparation for meetings conducted with CDER/CBER, including rehearsals and development of meeting requests and briefing books.
• Monitors the regulatory environment and commu