[Hiring] Senior Director Regulatory Affairs, Head of Global Labeling and Labeling Operations @argenx

Role Description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. 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.

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 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
• Team Leadership, People Development and Functional Evolution

Qualifications

• 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 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.

Requirements

• You create a culture of collaboration, excellence, and innovation that inspires team members to perform at their highest abilities.
• You are a connector, building relationships and partnering across the organization to achieve company goals.
• You excel in a fast-paced, results-driven, highly accountable environment.
• You are pragmatic, yet creative and innovative, and lead while “rolling up your sleeves” to get it done.
• You show strong leadership through a proven ability to build, motivate, mentor, and develop a team.
• You resonate with the values of argenx and are ready to drive the company culture.
• You combine strategic thinking with the ability to execute, both individually and through teams, to achieve operational excellence in the face of challenging goals.

Benefits

• The annual base salary hiring range for this position is $268,000.00 - $368,500.00 USD.
• This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies.
• Comprehensive benefits package, including but not limited to retirement savings plans, health benefits, and other benefits subject to the terms of the applicable plans and program guidelines.

Company Description

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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