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

Role: Senior regulatory leader responsible for U.S. FDA advertising and promotion compliance throughout the product lifecycle for argenx's autoimmune therapies, including VYVGART. Responsibilities: oversee approval of promotional materials across channels; serve as regulatory liaison with FDA OPDP; interpret enforcement actions; guide commercialization strategies related to labeling and claims; lead and develop the Ad/Promo team; advance digitally enabled, AI-driven regulatory processes; and contribute to long-term growth and compliance standards. Qualifications: 15+ years regulatory experience, with 5–7+ years focused on advertising and promotion; deep expertise in FDA regulations; proven leadership in matrix environments supporting product launches; strategic thinker with strong communication skills; digitally savvy with experience in AI-enabled workflows. High-value: autoimmune indications, biologics, product lifecycle management, FDA Ad/Promo landscape, cross-functional collaboration with Commercial, Medical Affairs, Legal, Market Access. Work Setup: US-based, capable of supporting multiple therapeutic area launches, with emphasis on innovation in regulatory operations.