Madrigal Pharmaceuticals
Vice President, Global Promotional Advertising and Regulatory Affairs
Madrigal Pharmaceuticals, Waltham, Massachusetts, United States, 02254
Vice President, Global Promotional Advertising and Regulatory Affairs
Join us as Vice President, Global Promotional Advertising & Regulatory Affairs at Madrigal Pharmaceuticals. This strategic role leads the regulatory strategy and oversight of all advertising, promotional, and scientific‑exchange communications for prescription pharmaceutical and biologic products across the U.S. and globally.
Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH). Our medication, Rezdiffra (resmetirom), is a once‑daily oral, liver‑directed THR‑β agonist that targets the key underlying causes of MASH and is the only FDA‑ and European Commission‑approved drug for moderate to advanced fibrosis.
Role Overview The Head of Global Promotional Advertising & Regulatory Affairs directs the regulatory strategy, review, and governance of all advertising, promotional, and scientific‑exchange communications, ensuring compliance with FDA regulations, enforcement precedent, industry codes of practice, and international laws. The role requires deep regulatory subject‑matter expertise, cross‑functional leadership, risk‑based decision making, and representation of the company in regulatory interactions.
Key Responsibilities
Develop and lead the global regulatory advertising & promotion (Ad & Promo) strategy for marketed products and pipeline assets.
Serve as regulatory subject‑matter expert for promotional communications, ensuring compliance with laws, guidance documents, and internal policies.
Manage and mentor staff supporting the promotional review process, including review of concepts, claims, safety/risk language, labeling consistency, and monitoring enforcement trends.
Act as primary liaison with regulatory agencies (e.g., FDA OPDP), including submissions, advisory requests, and responses to enforcement letters.
Provide strategic regulatory advice to cross‑functional stakeholders to facilitate timely and compliant promotional launch campaigns.
Develop, implement, and maintain SOPs, guidelines, training programs, quality metrics, and dashboards for the Ad & Promo review process.
Monitor and interpret regulatory developments and proactively update the business on implications.
Mentor, build, and lead the regulatory advertising & promotion team, fostering expertise and stakeholder engagement.
Support global/regional harmonization of advertising & promotion regulatory framework with international/regional leads.
Ensure appropriate database/record‑keeping for promotional materials and audit readiness.
Perform other duties as assigned.
Required & 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 review, general regulatory strategy, labeling knowledge, and commercial compliance.
Deep knowledge of U.S. FDA advertising & promotion and labeling regulations (including OPDP, Form 2253, enforcement letters).
Experience operating cross‑functionally in a matrixed environment, influencing without direct authority.
Strong strategic, analytical, and risk‑management mindset providing clear regulatory positions and business‑oriented advice.
Excellent verbal and written communication skills including preparing correspondence, briefing documents, and training materials.
Experience with promotional review systems/document management tools such as Veeva PromoMats and metrics tracking of review performance is preferred.
Leadership and team‑building experience (direct or indirect) preferred.
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 regulatory authorities on advisory comments, competitor complaints, or enforcement issues.
Experience developing or optimizing promotional review processes, SOPs, dashboards, and training programs.
Demonstrated ability to support digital/multi‑channel promotional communications in a regulatory context.
Leadership & Competencies
Strategic thinker aligning regulatory needs with commercial objectives.
High integrity and sound judgment, balancing opportunity and regulatory risk.
Influencer and collaborator, driving consensus in cross‑functional teams and communicating at senior leadership level.
Agile and adaptable, managing ambiguity and changing requirements.
Operational excellence orientation with continuous improvement focus.
Mentorship mindset, building team capability and fostering a culture of compliance and partnership.
Key Metrics/Success Measures
Timeliness and quality of promotional material review and approval.
Compliance metrics: minimal regulatory enforcement findings and internal audit findings.
Efficiency metrics: review cycle times, number of materials cleared, process improvement initiatives.
Stakeholder satisfaction from Commercial, Medical Affairs, and Legal/Compliance.
Regulatory risk mitigation: proactive identification of potential issues and strategy effectiveness.
Team development: growth of regulatory ad/promo team and training completion.
Alignment with business objectives, supporting new product launches.
Seniority Level Executive
Employment Type Full‑time
Job Function Marketing and Sales
Industries Pharmaceutical Manufacturing
Compensation Base salary is $316,000‑$386,000 per year, plus bonus, equity, and a comprehensive benefits suite.
Benefits Full‑time employees receive equity, flexible paid time off, medical, dental, vision, life and disability insurance, 401(k) with employer match, supplemental life insurance, legal services, mental health support, and other voluntary benefits, in accordance with applicable laws.
EEO Statement Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Accommodations We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com.
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Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH). Our medication, Rezdiffra (resmetirom), is a once‑daily oral, liver‑directed THR‑β agonist that targets the key underlying causes of MASH and is the only FDA‑ and European Commission‑approved drug for moderate to advanced fibrosis.
Role Overview The Head of Global Promotional Advertising & Regulatory Affairs directs the regulatory strategy, review, and governance of all advertising, promotional, and scientific‑exchange communications, ensuring compliance with FDA regulations, enforcement precedent, industry codes of practice, and international laws. The role requires deep regulatory subject‑matter expertise, cross‑functional leadership, risk‑based decision making, and representation of the company in regulatory interactions.
Key Responsibilities
Develop and lead the global regulatory advertising & promotion (Ad & Promo) strategy for marketed products and pipeline assets.
Serve as regulatory subject‑matter expert for promotional communications, ensuring compliance with laws, guidance documents, and internal policies.
Manage and mentor staff supporting the promotional review process, including review of concepts, claims, safety/risk language, labeling consistency, and monitoring enforcement trends.
Act as primary liaison with regulatory agencies (e.g., FDA OPDP), including submissions, advisory requests, and responses to enforcement letters.
Provide strategic regulatory advice to cross‑functional stakeholders to facilitate timely and compliant promotional launch campaigns.
Develop, implement, and maintain SOPs, guidelines, training programs, quality metrics, and dashboards for the Ad & Promo review process.
Monitor and interpret regulatory developments and proactively update the business on implications.
Mentor, build, and lead the regulatory advertising & promotion team, fostering expertise and stakeholder engagement.
Support global/regional harmonization of advertising & promotion regulatory framework with international/regional leads.
Ensure appropriate database/record‑keeping for promotional materials and audit readiness.
Perform other duties as assigned.
Required & 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 review, general regulatory strategy, labeling knowledge, and commercial compliance.
Deep knowledge of U.S. FDA advertising & promotion and labeling regulations (including OPDP, Form 2253, enforcement letters).
Experience operating cross‑functionally in a matrixed environment, influencing without direct authority.
Strong strategic, analytical, and risk‑management mindset providing clear regulatory positions and business‑oriented advice.
Excellent verbal and written communication skills including preparing correspondence, briefing documents, and training materials.
Experience with promotional review systems/document management tools such as Veeva PromoMats and metrics tracking of review performance is preferred.
Leadership and team‑building experience (direct or indirect) preferred.
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 regulatory authorities on advisory comments, competitor complaints, or enforcement issues.
Experience developing or optimizing promotional review processes, SOPs, dashboards, and training programs.
Demonstrated ability to support digital/multi‑channel promotional communications in a regulatory context.
Leadership & Competencies
Strategic thinker aligning regulatory needs with commercial objectives.
High integrity and sound judgment, balancing opportunity and regulatory risk.
Influencer and collaborator, driving consensus in cross‑functional teams and communicating at senior leadership level.
Agile and adaptable, managing ambiguity and changing requirements.
Operational excellence orientation with continuous improvement focus.
Mentorship mindset, building team capability and fostering a culture of compliance and partnership.
Key Metrics/Success Measures
Timeliness and quality of promotional material review and approval.
Compliance metrics: minimal regulatory enforcement findings and internal audit findings.
Efficiency metrics: review cycle times, number of materials cleared, process improvement initiatives.
Stakeholder satisfaction from Commercial, Medical Affairs, and Legal/Compliance.
Regulatory risk mitigation: proactive identification of potential issues and strategy effectiveness.
Team development: growth of regulatory ad/promo team and training completion.
Alignment with business objectives, supporting new product launches.
Seniority Level Executive
Employment Type Full‑time
Job Function Marketing and Sales
Industries Pharmaceutical Manufacturing
Compensation Base salary is $316,000‑$386,000 per year, plus bonus, equity, and a comprehensive benefits suite.
Benefits Full‑time employees receive equity, flexible paid time off, medical, dental, vision, life and disability insurance, 401(k) with employer match, supplemental life insurance, legal services, mental health support, and other voluntary benefits, in accordance with applicable laws.
EEO Statement Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Accommodations We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com.
#J-18808-Ljbffr