Global Labeling & Regulatory Strategy Director

Argenx; Oregon; Hybrid; USD 268,000 - 369,000; Full time

Benefits offered by this job

Incentive programs

Retirement plans

Health benefits

Inclusive environment

Job summary

argenx is seeking a Senior Director level Head of Global Labeling and Labeling Operations to lead the global labeling function across development, registration, and commercialization of its products. This senior regulatory leader will define and execute labeling strategy, partnering with FDA and regional regulators while guiding a cross-functional team.

The role includes building a high-performing labeling organization, overseeing CCDS/USPI/EU product information, and shaping lifecycle labeling

Qualifications

• Minimum 15 years in biopharma with substantial Regulatory Affairs and labeling experience.
• Proven track record leading FDA labeling negotiations for NDAs/BLA approvals or major new indications.
• Strong leadership of global labeling strategies across development, registration, and post‑approval lifecycle.

Responsibilities

• Define the global labeling vision and strategy across development and marketed products.
• Lead FDA labeling negotiations in partnership with US Regulatory Lead.
• Ensure labeling aligns with global regulatory strategy and lifecycle plans.
• Provide strategic guidance on indication wording, dosing, and safety information.
• Build and develop a high-performing global labeling organization with internal FTEs and external partners.
• Evolve the Target Product Label (TPL) process and labeling governance across programs.

Skills

Global labeling strategy

FDA negotiations

Regulatory leadership

Team leadership

Cross-functional collaboration

Education

Advanced scientific degree

Tools

CDDS

USPI

TPL process

Job description

argenx is seeking a Senior Director level Head of Global Labeling and Labeling Operations to lead the global labeling function across development, registration, and commercialization of its products. This senior regulatory leader will define and execute labeling strategy, partnering with FDA and regional regulators while guiding a cross-functional team.

The role includes building a high-performing labeling organization, overseeing CCDS/USPI/EU product information, and shaping lifecycle labeling