Senior Director, Global Labeling & Regulatory Strategy

argenx US Inc; United States; Remote; USD 268,000 - 369,000; Full time

Benefits offered by this job

Health benefits

Retirement savings plans

Incentive programs

Job summary

argenx seeks a Senior Director, Head of Global Labeling and Labeling Operations to define and drive the global labeling strategy across development, registration, and post‑approval lifecycle. You will translate clinical data into FDA‑ready labeling, lead the Label Working Group, and partner across Regulatory, Safety, and Commercial teams.

Based in the United States, you will build and lead a high‑performing labeling organization, oversee external partners, and shape labeling governance to

Qualifications

• 15+ years in biopharmaceutical regulatory affairs with labeling focus.
• Experience leading FDA labeling negotiations for NDAs/BLAs or major amendments.
• Proven ability translating efficacy and safety data into labeling positions.

Responsibilities

• Define global labeling vision, priorities, and strategy across lifecycle.
• Lead FDA negotiations on labeling in partnership with US Regulatory Lead.
• Ensure labeling aligns with global regulatory strategy and lifecycle plans.
• Provide strategic recommendations on evidence requirements and risks.
• Build and mentor a high‑performing global labeling organization.

Skills

Global labeling strategy

FDA negotiations

Regulatory leadership

Cross‑functional collaboration

Team leadership

Strategic reasoning

Lifecycle management

Executive communication

Education

Advanced scientific or clinical degree

Job description

argenx seeks a Senior Director, Head of Global Labeling and Labeling Operations to define and drive the global labeling strategy across development, registration, and post‑approval lifecycle. You will translate clinical data into FDA‑ready labeling, lead the Label Working Group, and partner across Regulatory, Safety, and Commercial teams.

Based in the United States, you will build and lead a high‑performing labeling organization, oversee external partners, and shape labeling governance to