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

🕒 June 2

🇺🇸 United States – Remote

💵 $268k - $368.5k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• Define and execute U.S. regulatory strategy for promotional materials across the product lifecycle • Serve as the primary regulatory authority for FDA advertising and promotion compliance • Lead regulatory oversight and approval for promotional and medical education materials • Drive a future focus through a digitally enabled, AI-forward regulatory capability • Interpret enforcement actions to inform internal standards • Partner cross-functionally to enable compliant product differentiation and value communication • Provide regulatory input into launch readiness, messaging frameworks, and lifecycle strategies • Lead and scale U.S. Ad/Promo capabilities to support multiple launches across therapeutic areas • Future-proof the MRC/MMRC process to align with automation

🎯 Requirements

• 15+ years of regulatory experience with 5–7+ years in Ad/Promo roles • Deep expertise in FDA Ad/Promo landscape • Proven leadership in matrixed environments and experience supporting product launches • Strong strategic mindset and executive communication skills • Digitally savvy leader comfortable operating in AI-enabled environments • Ability to innovate and evolve regulatory processes

🏖️ Benefits

• retirement savings plans • health benefits and other benefits subject to the terms of the applicable plans and program guidelines