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

argenx

7d•$268,000 - $368,500

About The Position

argenx is seeking a senior regulatory leader to lead and evolve its global labeling function in support of the development, registration, and commercialization of current and future products. The role defines and executes global labeling strategy across product lifecycles and serves as the company’s senior subject-matter expert on labeling. It translates clinical evidence into scientifically substantiated labeling proposals and guides labeling strategy and negotiations with global regulatory agencies, particularly the FDA. As a member of the global regulatory leadership team, this leader partners with Clinical Development, Technical Operations/Device, Safety, Medical Affairs, Commercial, Market Access, Legal, and regional Regulatory colleagues. The role ensures that labeling informs development and evidence-generation decisions, supports scientifically sound product differentiation, and maintains consistent, compliant labeling across markets. It combines strategic leadership with hands-on responsibility for selected high-priority programs. The position leads and develops internal staff, manages consultants and external resources, and advances the labeling function through implementation of a Target Product Label (TPL) process and development of the internal Label Working Group and Global Labeling Committee. The leader oversees labeling strategy and lifecycle management, team development, functional processes and systems, capacity planning, budgets, vendor performance, compliance, and inspection readiness. Candidates must be based in the United States (EST time zone), Belgium, or Switzerland. For US applicants, the stated annual base salary hiring range is $268,000–$368,500. The role is eligible for short-term and long-term incentive programs and includes a comprehensive benefits package, including retirement savings plans and health benefits.

Requirements

Ideally, at least 15 years of relevant biopharmaceutical industry experience, including substantial Regulatory Affairs experience and at least 7 years focused on labeling strategy.
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.
Ability to interpret clinical efficacy and safety evidence and translate it into defensible labeling positions and negotiation strategies.
Experience developing and maintaining TPLs, CCDS, USPI, and EU product information.
Strong understanding of FDA labeling requirements and expectations, with working knowledge of EU and other major-market labeling requirements.
Experience implementing or evolving a TPL process and strengthening cross-functional labeling governance.
Leadership experience managing and developing internal employees, overseeing consultants, and working effectively in a highly matrixed environment.
Excellent executive communication, negotiation, presentation, and cross-functional influencing skills.
Ability to foster collaboration, excellence, and innovation; build relationships across the organization; and perform in a fast-paced, results-driven, highly accountable environment.
Pragmatic, creative, and innovative approach, with the ability to lead hands-on and execute independently and through teams.
Proven ability to build, motivate, mentor, and develop a team.
Ability to combine strategic thinking with execution and achieve operational excellence against challenging goals.
Must be based in the United States (EST time zone), Belgium, or Switzerland.

Nice To Haves

Advanced scientific or clinical degree preferred.
Experience building or evolving a labeling function within a rapidly growing biopharmaceutical organization.
Experience supporting product launches and major lifecycle milestones.
Biologics, specialty, or rare disease experience.

Responsibilities

Define the global labeling vision, priorities, and strategy across development-stage and marketed products.
Serve as senior regulatory authority for labeling strategy and lead preparation for and execution of FDA labeling negotiations in partnership with the US Regulatory Lead.
Integrate labeling strategies with global regulatory strategy, clinical development, safety evaluation, commercialization, and lifecycle planning.
Provide senior leadership with recommendations on labeling opportunities, evidence requirements, regulatory risks, and negotiation trade-offs.
Build, lead, and develop the global labeling organization, including internal employees, consultants, and external service providers.
Lead 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 and lifecycle changes, including new indications, formulations, product presentations, patient populations, and safety updates.
Ensure proposed labeling reflects the totality of available evidence and identify evidence gaps and potential regulatory challenges.
Provide strategic oversight of regional and country labeling, aligning it with core labeling while managing justified local differences.
Partner with Safety to assess emerging information and ensure timely updates to core and local labeling.
Partner with the Head of US Advertising, Promotion and Strategic Commercialization on approved labeling, labeling limitations, and compliant claims and communications.
Provide strategic guidance on indication wording, patient populations, dosing, limitations of use, safety information, and clinical study results.
Develop labeling negotiation strategies, including objectives, evidence-based arguments, alternative wording, fallback positions, and escalation pathways.
Advise senior leadership on clinical, patient, regulatory, and business implications of potential labeling outcomes.
Monitor labeling precedents, competitor labels, and evolving regulatory expectations in key regions and translate findings into recommendations.
Implement and evolve a Target Product Label process across development programs and relevant lifecycle opportunities; use it to identify evidence gaps and inform study design, endpoints, analyses, and development decisions.
Develop the internal Label Working Group as a forum for proactive strategy, integrated scientific assessment, and timely decisions; connect TPL development with core, regional, and 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.
Set team objectives, responsibilities, and performance expectations, and align resources with portfolio priorities and business needs.
Mentor and coach team members, support individual development and succession planning, and build scientific, strategic, negotiation, and leadership capabilities.
Manage consultant scope, deliverables, quality, performance, and knowledge transfer.
Foster a collaborative and accountable environment that encourages constructive challenge and 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.