Sr. Dir. Regulatory Affairs, Head of Global Labeling and Labeling Operations

Job description

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 company’s 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 ManagementLead 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 differences. Partner with Safety to assess emerging information and ensure appropriate, timely updates to core and local labeling. Partner with the Head of US Advertising, Promotion and Strategic Commercialization to ensure a shared understanding of approved labeling, labeling limitations, and implications for compliant claims and communications. Lead labeling strategy throughout development, registration, and postapproval lifecycle management. Provide strategic guidance on indication wording, patient populations, dosing, limitations of use, safety information, and presentation of clinical study results. Partner to develop labeling negotiation strategies, including objectives, evidence-based arguments, alternative wording, fallback positions, and escalation pathways. Advise senior leadership on the clinical, patient, regulatory, and business implications of potential labeling outcomes. Monitor labeling precedents from key regions (eg US, EU, Japan), competitor labels, and evolving regulatory expectations, translating intelligence into actionable recommendations. Evolve the labeling function through the strategic implementation of a Target Product Label (TPL) process across development programs (early to late development) and relevant lifecycle opportunities. Evolve the TPL process to maximize ability to identify gaps between desired labeling and available or planned evidence, informing study design, endpoints, analyses, and development decisions. Evolve the internal Label Working Group into an effective forum for proactive labeling strategy, integrated scientific assessment, and timely decision-making. Establish clear connections between TPL development, core labeling decisions, regional labeling proposals, and health-authority negotiation positions. Drive evidence-based resolution of differing views and escalate material strategic issues to the appropriate governance body. Provide training and guidance to strengthen labeling capabilities and shared accountability across the organization. Team Leadership, People Development and Functional EvolutionBuild, lead, and manage the global labeling team, with direct responsibility for internal FTEs and oversight of consultants and external service providers. Set clear objectives, responsibilities, and performance expectations; align resources with portfolio priorities and business needs. Mentor and coach team members through regular feedback, individual development planning, and opportunities to lead increasingly complex labeling activities. Develop scientific, strategic, negotiation, and leadership capabilities within the team; support career development and succession planning. Manage consultant scope, deliverables, quality, performance, and knowledge transfer to strengthen internal capabilities. Foster a collaborative, accountable environment in which team members constructively challenge assumptions and develop evidence-based solutions. Evolve fit-for-purpose labeling processes, systems, standards, and interfaces with labeling operations, regional Regulatory, Safety, and packaging/artwork functions. Oversee functional capacity planning, budgets, vendor performance, labeling compliance, and inspection readiness. Desired Skills and Experience:Ideally, a minimum of 15 years of relevant biopharmaceutical industry experience, including substantial Regulatory Affairs experience and at least 7 years focused on labeling strategy. Advanced scientific or clinical degree preferred. Deep, hands-on expertise in global labeling strategy across development, registration, and postapproval lifecycle management. Demonstrated experience personally leading FDA labeling negotiations for original NDA/BLA approvals and/or major supplemental indications. Proven ability to interpret clinical efficacy and safety evidence and translate it into defensible labeling positions and successful negotiation strategies. Experience developing and maintaining TPLs, CCDS, USPI, and EU product information. Strong understanding