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. Management of regulatory activities for all projects assigned to the Regulatory CMC group. Ensure regulatory conformance for commercial products through effective change management. Maintain a high level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy. Manage budget associated with group activities and provide regulatory strategy for life-cycle management. Provide regulatory support for due diligence activities associated with the assessment of business opportunities. Key Accountabilities Business Operations Management of all regulatory activities for development and commercial projects assigned to the group: Act or assign a regulatory representative for each project team. Oversee the development and implementation of regulatory submission strategy. Manage the planning, preparation and technical review of regulatory submissions and ensure submissions are completed to meet required/established timelines. Collaborate on the development and/or optimization of product development strategy to be consistent with regulatory requirements. Interact with regulatory authorities to address regulatory strategy, milestone meetings, queries and regulatory actions. Business Strategy Maintain a high level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products. Provide regulatory guidance and strategy for life-cycle management planning and development for commercial products. Anticipate the impact of the changing regulatory environment on development plans and registration strategy. Develop and implement strategies to proactively influence/address these changes. Compliance Ensure regulatory conformance for commercial products through effective change management. Fiscal Discipline Manage budget associated with group activities including submission fees (ex-US), business travel and training. Due Diligence Provide regulatory support for due diligence activities associated with the assessment of business opportunities. Qualifications Education & Experience +20 years of overall relevant experience. Graduate degree in a scientific/technical discipline (Ph.D., MS Science or PharmD.) with a minimum 12 years pharmaceutical drug development experience and 7 years hands-on regulatory experience. Proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning. Strong knowledge of regulations/guidelines governing development and commercialization of pharmaceuticals. Basic computer skills (MS Office, Excel and Adobe Acrobat). Experience supporting and conducting due diligence activities. Knowledge Strong knowledge of regulations/guidelines governing pharmaceutical/biologics development is required. Familiarity/understanding of FDA regulatory processes (experience with ex-US regulatory authorities/processes is required) Skills & Abilities Ability to communicate clearly and concisely with senior management and regulatory authorities. Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities. Experience managing multiple headcount and developing/mentoring junior staff. Ability to effectively delegate tasks and hold others accountable. Physical Requirements Occasional business travel. Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusiv