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

🕒 6 dias atrás

🌐 Estados Unidos, Bélgica, +1 outros países – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇧🇪 Bélgica – Remoto 🇨🇭 Suíça – Remoto

💵 $268.000 - $368.500 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 0%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 6 dias.
• As vagas desta empresa costumam ser preenchidas em 34 dias.

Candidatar-se

Encontrar Vagas Remotas Similares

argenx

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2008

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A argenx é uma empresa de biotecnologia comprometida em melhorar a vida dos pacientes por meio de inovação em imunologia. A empresa concentra-se no desenvolvimento de terapias inovadoras baseadas em anticorpos para tratar doenças autoimunes graves. Adotando uma abordagem colaborativa com cientistas pioneiros e parceiros acadêmicos, a argenx acelera a descoberta de anticorpos terapêuticos que têm como alvo vias específicas das doenças. Os produtos proprietários da empresa, como o efgartigimod, têm como objetivo tratar doenças em que os anticorpos IgG são patogênicos. A argenx enfatiza a inovação, a ciência da colaboração e abordagens centradas no paciente em sua missão de oferecer soluções médicas transformadoras.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo