Senior Director, Global Labeling & Regulatory Strategy

argenx; United States; On-site; USD 268,000 - 369,000; Full time

Job summary

argenx is searching for a Senior Director, Head of Global Labeling and Labeling Operations to guide the global labeling function through development, registration, and post‑approval lifecycle management. The role anchors strategy, standards, and governance while shaping evidence-driven labeling positions for US and EU markets.

You will lead a cross‑functional team and partner with Safety, Clinical Development, and Commercial to ensure compliant, impactful labeling decisions.

Qualifications

• Minimum of 15 years in biopharmaceutical regulatory affairs with deep labeling experience.
• Proven leadership of global labeling strategy across development and lifecycle.
• Experience leading FDA labeling negotiations for NDA/BLA approvals or major indications.
• Strong strategic thinking, risk assessment, and cross-functional influence.
• Ability to build and develop a high-performing labeling organization.

Responsibilities

• Define global labeling vision, priorities, and strategy across products.
• Lead FDA negotiations in collaboration with US Regulatory Lead.
• Integrate labeling with global regulatory, clinical, safety, and commercial plans.
• Provide senior leadership with evidence-based labeling recommendations and trade-offs.
• Build and manage internal FTEs, consultants, and external providers.

Job description

argenx is searching for a Senior Director, Head of Global Labeling and Labeling Operations to guide the global labeling function through development, registration, and post‑approval lifecycle management. The role anchors strategy, standards, and governance while shaping evidence-driven labeling positions for US and EU markets.

You will lead a cross‑functional team and partner with Safety, Clinical Development, and Commercial to ensure compliant, impactful labeling decisions.