Senior Manager, European Regulatory Systems

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. This 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 our medication for the treatment of compensated MASH cirrhosis (F4c).About the Role:We are seeking a strategic and detail-oriented Senior Manager, European Regulatory Systems to lead and optimize our regulatory systems across Europe. In this role, you will oversee the management, enhancement, and compliance of regulatory information systems supporting our products across the EU, UK, and wider EMEA region. You will collaborate closely with Regulatory Affairs, IT, Quality, and external partners to ensure seamless operations and regulatory excellence.Key Responsibilities:Regulatory Systems Leadership: Lead the development, implementation, and maintenance of regulatory information management systems (RIMS), electronic document management systems (EDMS), and submission tools.Compliance and Quality: Ensure regulatory systems comply with European Medicines Agency (EMA), national authorities, and global regulatory requirements (e.g., IDMP, SPOR, xEVMPD).Process Improvement: Design and drive continuous improvement initiatives for system workflows, data integrity, and user experience across the regulatory organization.Project Management: Manage key system upgrades, migrations, and integrations, partnering with IT and vendors to ensure projects meet business needs, timelines, and budgets.Data Stewardship: Oversee the quality, consistency, and governance of regulatory data to support accurate submissions and reporting requirements.Stakeholder Collaboration: Act as the main point of contact for system users across Regulatory Affairs, Quality Assurance, Pharmacovigilance, and Commercial teams.Training and Change Management: Develop and deliver training programs and change management strategies to maximize adoption and effective use of regulatory systems.Vendor Management: Manage relationships with external technology providers, consultants, and service providers, ensuring contract compliance and performance.Qualifications:Bachelor's degree in Life Sciences, Computer Science, Regulatory Affairs, or related field (Master’s preferred).Minimum of 7–10 years' experience in regulatory systems management within the pharmaceutical, biotech, or medical device industry.Deep understanding of European regulatory frameworks (e.g., EMA, national agencies) and familiarity with global requirements (e.g., FDA, Health Canada) is a plus.Strong knowledge of RIMS, EDMS, and electronic submission standards (eCTD, NeeS).Experience with IDMP, xEVMPD, SPOR, and/or EU CTR preferred.Proven leadership and project management skills.Excellent problem-solving, communication, and stakeholder management abilities.What We Offer:Opportunity to influence regulatory strategy and digital transformation at a European and global scale.A collaborative, innovative environment committed to excellence and integrity.Competitive salary, bonus, and comprehensive benefits package.Flexible work arrangements (hybrid)