Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

argenx is seeking a senior regulatory leader to define and execute U.S. regulatory strategy for promotional materials across the product lifecycle. This role serves as the primary regulatory authority for FDA advertising and promotion compliance and acts as a strategic business partner to Commercial, Medical Affairs, Legal, and Market Access to enable compliant, differentiated launch and in-market execution. The role contributes to broader commercialization strategy, including labeling, claims optimization, and lifecycle management.

Roles and Responsibilities:

• Provide senior regulatory expertise in FDA advertising and promotion requirements, including OPDP guidance, enforcement trends, and industry best practices.
• Lead regulatory oversight and approval for promotional and medical education materials (HCP, consumer, digital, omnichannel, speaker programs, and congress materials).
• Drive a future focus through a digitally enabled, AI-forward regulatory capability, including evolving content creation, modular content, and review processes.
• Serve as primary regulatory interface with FDA OPDP, including advisory comments, voluntary submissions, and responses to inquiries.
• Interpret enforcement actions (Untitled Letters, Warning Letters) 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, artificial intelligence, and modern go-to-market models.

For applicants in the United States: The annual base salary hiring range for this position is $268,000.00 - $368,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.