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

argenx

Senior regulatory leader defining and executing U.S. regulatory strategy for promotional materials.

Posted 6/2/2026full-timeRemote • 🇺🇸 United StatesLead💰 $268,000 - $368,500 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyFDA compliancepromotional materials oversightmedical education materials approvalproduct lifecycle managementregulatory inputlaunch readinessmessaging frameworksautomation in regulatory processesAI-enabled environments

Soft Skills

leadershipstrategic mindsetexecutive communicationcross-functional collaborationinnovationadaptabilitycompliance focusvalue communicationmatrixed environment experiencefuture-focused thinking