Senior Director, Regulatory Affairs – Head of Global Labeling and Labeling Operations

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🔥 6 minutes ago

🌐 United States, Belgium, +1 more countries – Remote

🇺🇸 United States – Remote 🇧🇪 Belgium – Remote 🇨🇭 Switzerland – Remote

💵 $268k - $368.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• 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 • 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 and develop a high-performing global labeling organization • Lead development and maintenance of CCDS, USPI, and EU product information • Establish scientifically substantiated labeling positions for registrations, new indications, formulations, patient populations, safety updates, and lifecycle changes • Provide strategic oversight of regional and country labeling • Partner with Safety on emerging information and timely labeling updates • Partner with Advertising, Promotion and Strategic Commercialization on approved labeling and compliant claims • Lead labeling strategy throughout development, registration, and postapproval lifecycle management • Provide guidance on indication wording, patient populations, dosing, limitations of use, safety information, and clinical study results • Develop labeling negotiation strategies and advise senior leadership on potential outcomes • Monitor labeling precedents, competitor labels, and evolving regulatory expectations • Implement and evolve the Target Product Label process • Evolve the internal Label Working Group and Global Labeling Committee • Drive evidence-based resolution of differing views and escalate strategic issues • Provide training and guidance to strengthen labeling capabilities • Manage internal FTEs, consultants, and external service providers • Set objectives, responsibilities, performance expectations, and resource alignment • Mentor and coach team members and support career development and succession planning • Manage consultant scope, deliverables, quality, performance, and knowledge transfer • Evolve labeling processes, systems, standards, and interfaces with related functions • Oversee capacity planning, budgets, vendor performance, labeling compliance, and inspection readiness

🎯 Requirements

• Ideally, a minimum of 15 years of relevant biopharmaceutical industry experience • 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 of FDA labeling requirements and expectations, together with working knowledge of EU and other major-market labeling requirements • Demonstrated experience implementing or evolving a TPL process and strengthening cross-functional labeling governance • Proven leadership experience managing and developing internal FTEs, overseeing consultants, and operating effectively in a highly matrixed environment • Experience building or evolving a labeling function within a rapidly growing biopharmaceutical organization is desirable • Experience supporting product launches and major lifecycle milestones; biologics, specialty, or rare disease experience is a plus • Excellent executive communication, negotiation, presentation, and cross-functional influencing skills • Strong leadership through a proven ability to build, motivate, mentor, and develop a team • Candidates must be based in US (EST time zone), Belgium or Switzerland to be considered for this role

🏖️ Benefits

• Short-term incentive programs • Long-term incentive programs • Retirement savings plans • Health benefits • Comprehensive benefits package

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