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Madrigal Pharmaceuticals · 1 day ago

Vice President, Global Promotional Advertising and Regulatory Affairs

Waltham, MA

Full-time

Onsite

Director/Executive

$316K/yr - $386K/yr

20+ years exp

Madrigal Pharmaceuticals is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The Vice President of Global Promotional Advertising and Regulatory Affairs will lead the regulatory strategy and oversee all advertising and promotional communications for pharmaceutical products, ensuring compliance with regulatory requirements while supporting commercial objectives.

BiopharmaBiotechnologyMedical DevicePharmaceutical

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 assigned

Qualification

Regulatory affairs expertiseFDA regulations knowledgeAdvertisingPromotion strategyCross-functional leadershipLife Sciences degreePromotional review systemsTeam building experienceAnalytical mindsetCommunication skillsMentorship mindset

Required

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

Preferred

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

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

Demonstrated ability to support digital‐/multi-channel promotional communications (e.g., online, social media) in a regulatory context