Head of U.S. Regulatory Advertising & Promotion and Strategic Commercialization

arGEN-X N.V.

Job Overview

Location

United States - Remote

Job Type

Full-time

Full Job Description

📋 Description

• Lead U.S. regulatory strategy for promotional materials across the entire product lifecycle, ensuring full compliance with FDA advertising and promotion requirements, including OPDP guidance and enforcement trends.
• Serve as the primary regulatory authority and point of contact for FDA OPDP, managing advisory comments, voluntary submissions, and responses to inquiries such as Untitled Letters and Warning Letters.
• Oversee regulatory review and approval of all promotional and medical education materials, including HCP-facing, consumer, digital, omnichannel, speaker programs, and congress-related content.
• Drive the modernization of regulatory processes by integrating AI-enabled tools, modular content systems, and automation into the Medical Review Committee (MRC/MMRC) workflow to support scalable, efficient compliance.
• Partner cross-functionally with Commercial, Medical Affairs, Legal, and Market Access teams to enable compliant, differentiated messaging and value communication that supports product launches and in-market execution.
• Interpret FDA enforcement actions and translate them into updated internal standards, policies, and training materials to mitigate risk and enhance compliance culture.
• Build, lead, and mentor a high-performing U.S. regulatory advertising and promotion team, establishing governance frameworks, decision-making protocols, and consistency across brands and therapeutic areas.
• Provide strategic regulatory input into launch readiness, messaging frameworks, lifecycle management, and claims optimization for multiple assets and indications.
• Future-proof the regulatory function by innovating processes to align with evolving go-to-market models, digital engagement channels, and AI-driven content creation.
• Balance commercial objectives with regulatory compliance through risk-based decision-making, ensuring promotional materials are both impactful and legally defensible.
• Deliver training and guidance to internal stakeholders to elevate regulatory literacy and promote adherence across the organization.
• Contribute to the long-term vision and growth strategy for argenx by aligning regulatory capabilities with the company’s expansion across dozens of severe autoimmune diseases.
• Ensure all promotional activities reflect argenx’s commitment to innovation, patient impact, and scientific integrity while maintaining strict adherence to U.S. regulatory standards.

🎯 Requirements

• 15+ years of regulatory experience with 5–7+ years specifically in FDA advertising and promotion roles
• Deep expertise in FDA Ad/Promo landscape, including OPDP guidance, enforcement trends, and industry best practices
• Proven leadership experience in matrixed environments with a track record of supporting successful product launches
• Strong strategic mindset and executive communication skills
• Digitally savvy leader with experience in AI-enabled, automated regulatory processes and modern content systems
• Ability to innovate and evolve regulatory workflows to support scalable, multi-asset commercialization

🏖️ Benefits

• Annual base salary range of $268,000.00 – $368,500.00 USD
• Eligibility to participate in short-term and long-term incentive programs
• Comprehensive benefits package including retirement savings plans and health benefits
• Remote work opportunity across the United States
• Inclusive, equal opportunity employer environment with no discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other protected characteristics
• Access to argenx’s mission-driven culture focused on transforming immunology and improving patient lives

Skills & Technologies

Remote

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arGEN-X N.V.

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About arGEN-X N.V.

arGEN-X is a global immunology company focused on developing a pipeline of antibody-based therapies for patients suffering from severe autoimmune diseases and cancer. The company leverages its powerful FcRn antagonist technology and broad pipeline to address a range of debilitating conditions. arGEN-X is committed to transforming the standard of care for these diseases and improving patient outcomes. Their approach involves deep scientific understanding of immunology and a dedication to innovation, aiming to deliver breakthrough treatments to those in need. They are driven by a mission to make a meaningful difference in the lives of patients worldwide.

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