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.
• Balance compliance and commercial objectives through risk-based decision making.
• Contribute to shaping long-term Vision and growth strategy across multiple assets and indications.

Leadership & Governance:

• Build, lead, and mentor a high-performing U.S. regulatory Ad/Promo team.
• Establish governance frameworks and decision-making processes for promotional review.
• Drive consistency in regulatory interpretation across brands and therapeutic areas.
• Provide training and guidance to internal stakeholders.

Education, Qualifications and Experience:

• 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.

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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.

This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.