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

argenx

11d•$268,000 - $368,500•Remote

About The Position

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.

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.

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.
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.