Vice President, Global Promotional Advertising and Regulatory Affairs

Location: Conshohocken

## 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 –…