Vice President, Global Promotional Advertising and Regulatory Affairs

## 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 Head of Global Promotional Advertising & Regulatory Affairs leads and oversees the regulatory strategy, review and governance of all advertising, promotional, and scientific‐exchange communications (both internal and external) for prescription pharmaceutical / biologic products in the U.S. and internationally. This role ensures that promotional materials, campaigns, labeling, and other communications comply with applicable regulatory requirements (e.g., Food and Drug Administration (FDA) regulations, enforcement precedent, industry codes of practice, international laws and regulations) while enabling the commercial objectives of the organization. Drawing on industry benchmarks, the role requires deep regulatory subject matter expertise, cross-functional leadership (Marketing, Medical Affairs, Legal / Compliance, Regulatory Operations), and the ability to guide risk-based decisions, represent the company in regulatory interactions (e.g., FDA’s Office of Prescription Drug Promotion (OPDP)), and drive high-quality processes and metrics.Key Responsibilities
• Develop and lead the global regulatory advertising & promotion (Ad & Promo) strategy for the company’s marketed products and pipeline assets, in alignment with brand / commercial plans and overall regulatory strategy.
• Serve as the regulatory subject matter expert for promotional communications : advertising, sales aids, digital channels, medical education, disease awareness, conference exhibits, and scientific exchange materials. Ensure all materials comply with applicable laws, regulations, guidance documents, and internal policies (e.g., FDA OPDP, state laws, industry codes, international laws and regulations).
• Manage and mentor staff supporting the promotional review process including review of concepts, claims, safety / risk language (e.g., ISI / brief summary), and ensure labeling consistency. Monitor and respond to enforcement trends, advisory comments, and regulatory inquiries.
• Manage and mentor staff and / or act directly as a primary liaison with regulatory agencies (e.g., FDA OPDP), including submissions (e.g., Form 2253), advisory requests, and responses to enforcement letters or competitor complaints.
• Provide strategic regulatory advice and risk-based assessments to cross-functional stakeholders (Commercial / Marketing, Medical Affairs, Legal / Compliance, Regulatory Affairs operations), facilitating timely and compliant promotional launch campaigns and ongoing support for marketed products.
• Develop, implement and maintain standard operating procedures (SOPs), guidelines, training programs, quality metrics and dashboards for the Ad & Promo review process, ensuring operational excellence and continuous improvement.
• Monitor and interpret regulatory developments (e.g., FDA guidance updates, industry enforcement actions, global codes of practice) and proactively update the business on implications for promotional communications and risk mitigation.
• Mentor, build, and lead the regulatory advertising & promotion team – fostering subject matter expertise, leadership, collaboration, and stakeholder engagement across the organization.
• Support global / regional harmonization of advertising & promotion regulatory framework, including collaboration with international / regional regulatory Ad & Promo leads, to ensure consistency where cross-border materials or campaigns are used.
• Ensure appropriate database / record-keeping for promotional materials, including submissions, approvals, regulatory correspondence, internal review archives, and audit readiness
• Other duties as assignedRequired & Desired Qualifications
• Bachelor’s degree in Life Sciences (e.g., Biology, Chemistry, Pharmacy) required; advanced degree (PharmD, PhD, MS) strongly preferred.
• 20+ years of relevant experience in regulatory affairs advertising & promotion (Ad / Promo) review, general regulatory strategy and labeling knowledge, and commercial compliance. Minimum of 10–15 years of experience in the pharmaceutical / biologics industry.
• Deep knowledge of U.S. FDA advertising & promotion and labeling regulations (including but not limited to OPDP, Form 2253 submissions, enforcement letters), and ideally familiarity with global regulatory codes of practice and international Ad / Promo requirements.
• Demonstrated ability to operate cross-functionally in a matrixed environment, collaborate with Commercial, Medical Affairs, Legal / Compliance, Regulatory, and other stakeholders, influencing without direct authority.
• Strong strategic, analytical, and risk-management mindset : ability to interpret complex regulatory standards, provide clear regulatory positions and business‐oriented advice, and support launch assets and marketed brands.
• Excellent verbal and written communication skills; ability to articulate regulatory rationale, prepare correspondence / briefing documents for senior management, and deliver training.
• Experience with promotional review systems / document management tools (e.g., Veeva PromoMats) and metrics / tracking of review performance is preferred.
• Leadership and team building experience (either direct or indirect) preferred, with ability to mentor and develop regulatory professionals.Preferred / Desirable
• Experience in a therapeutic area with high regulatory scrutiny (e.g., oncology, rare diseases, biologics) or major product launches.
• Global / regional experience (non‐U.S.) in advertising & promotion regulatory matters or global brand support.
• Experience working with or interacting with regulatory authorities on advisory comments, competitor complaints or enforcement issues.
• Experience developing or optimizing promotional review processes, SOPs, dashboards, and training programs to drive operational efficiency and compliance robustness.
• Demonstrated ability to support digital‐ / multi-channel promotional communications (e.g., online, social media) in a regulatory context.Leadership & Competencies
• Strategic thinker, able to align regulatory needs with commercial objectives.
• High integrity and sound judgment : able to balance business opportunity and regulatory risk.
• Influencer and collaborator : able to drive consensus in cross-functional teams, communicate effectively at senior leadership level.
• Agile and adaptable : able to work in a dynamic, fast-paced environment, manage ambiguity and changing requirements.
• Operational excellence orientation : seeks continuous improvement in process, metrics, systems.
• Mentorship mindset : able to build team capability, teach / adapt regulatory updates, foster a culture of compliance and business partnership.Key Metrics / Success Measures
• Timeliness and quality of promotional material review and approval for assigned products / campaigns.
• Compliance metrics : zero or minimal regulatory enforcement findings, internal audit findings related to

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