Manager, MRC Operations REQ-4829

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 looking for a Senior Director level Head of Global Labeling and Labeling Operations to lead and evolve its global labeling function in support of the continued development, registration, and successful commercialization of its existing and future marketed products.

Key Accountabilities and Responsibilities:

This individual is a senior regulatory leader responsible for defining and executing global labeling strategy across the product lifecycle. The role serves as the companys senior subject-matter expert on labeling strategy, bringing deep experience translating clinical evidence into scientifically substantiated labeling proposals to inform labeling strategy and negotiations with global regulatory agencies, in particular the US Food and Drug Administration (FDA).

The person in this role is a key member of the global regulatory leadership team and partners closely with Clinical Development, Technical Operations/Device, Safety, Medical Affairs, Commercial, Market Access, Legal, and regional Regulatory colleagues. This leader ensures labeling considerations inform development and evidence-generation decisions, supports scientifically sound product differentiation, and maintains consistent, compliant labeling across markets.

The role combines strategic leadership with hands-on execution, including direct responsibility for selected high-priority programs. This individual will lead and develop internal FTEs, manage consultants and external resources, and evolve the labeling function through the strategic implementation of a Target Product Label process and continued development of the internal Label Working Group and Global Labeling Committee.

The key responsibilities for this individual are:

Define the global labeling vision, priorities, and strategy across development-stage and marketed products. Serve as the senior regulatory authority for labeling strategy and lead preparation for and execution of FDA labeling negotiations, in partnership with the US Regulatory Lead. Ensure labeling strategies are integrated with global regulatory strategy, clinical development, safety evaluation, commercialization, and lifecycle planning. Provide senior leadership with clear recommendations on labeling opportunities, evidence requirements, regulatory risks, and negotiation trade-offs. Build and develop a high-performing global labeling organization, with accountability for internal FTEs, consultants, and external service providers.

Your primary areas of focus are:

Global Labeling Strategy and Lifecycle Management Lead the development and maintenance of Company Core Data Sheets (CCDS), US Prescribing Information (USPI), and EU product information, in partnership with regional Regulatory colleagues. Establish scientifically substantiated labeling positions for initial registrations, new indications, formulations/product presentations, patient populations, safety updates, and other lifecycle changes. Ensure proposed labeling is supported by the totality of available evidence, with clear identification of evidence gaps and potential regulatory challenges. Provide strategic oversight of regional and country labeling, ensuring alignment with core labeling while appropriately managing justified local d