Senior Director, Regulatory Affairs

🕒 Outubro 2

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $211.200 - $281.200 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 1%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 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

BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Develop and execute integrated U.S. regulatory strategies for assigned products and programs across clinical development, registration, post-approval commitments, and lifecycle management • Provide authoritative U.S. regulatory advice to global regulatory leaders, development teams, governance committees, and senior management • Assess strategic options, risks, trade-offs, and mitigation plans and integrate U.S. regulatory considerations into global strategies • Serve as the primary regulatory leader for FDA engagement, planning, leading, and negotiating formal and informal interactions • Oversee strategy, preparation, quality, and timely submission of INDs, NDAs, BLAs, supplements, amendments, meeting packages, briefing documents, responses to information requests, and other U.S. regulatory filings • Incorporate U.S. regulatory requirements and FDA expectations into clinical development plans, evidence-generation strategies, labeling plans, and commercialization and lifecycle decisions • Lead regulatory risk assessment and critical issue management, escalating significant risks and driving cross-functional alignment on mitigation and execution • Maintain expert knowledge of FDA regulations, guidance, policy developments, and precedents and evaluate portfolio implications • Build partnerships with Clinical Development, Medical, Safety, Biostatistics, Clinical Operations, CMC, Quality, Legal, Commercial, and other functions • Represent Regulatory Affairs on senior cross-functional teams and governance forums and communicate complex regulatory matters to stakeholders • Anticipate high-impact portfolio or program regulatory risks and direct mitigation, escalation, and risk-acceptance decisions • Shape regulatory practices, operating approaches, innovation, future-state organizational capability, procedures, and process improvements • Recruit, develop, coach, and retain regulatory talent; establish priorities and performance expectations • Provide direct and matrixed supervision, capability building, succession planning, performance management, and development of a high-performing U.S. regulatory organization • Represent the company in external industry forums and regulatory policy discussions as needed

🎯 Requisitos

• 15+ years of experience in the pharmaceutical or biotechnology industry, including significant progressive experience in U.S. Regulatory Affairs and leadership of complex development programs • Bachelor’s degree in a scientific or health-related discipline required • Advanced scientific, medical, pharmacy, or regulatory degree preferred • Demonstrated leadership of complex U.S. regulatory strategies across multiple programs • Experience in both early- and late-stage oncology preferred • Demonstrated success as a U.S. regulatory lead with direct FDA interaction experience and significant regulatory accomplishments across development, registration, and lifecycle management • Expert knowledge of U.S. drug development regulations, guidance, policy trends, and submission requirements, including INDs and NDAs and/or BLAs • Experience with expedited development programs preferred • Experience developing and executing integrated regulatory strategies for complex programs • Oncology and both small-molecule and biologic experience preferred where relevant to the portfolio • Proven ability to lead high-stakes FDA interactions, negotiate effectively, resolve ambiguous or precedent-setting issues, and communicate clear recommendations to senior leaders • Strong strategic and business acumen • Ability to balance patient, scientific, regulatory, operational, and commercial considerations and make sound decisions under uncertainty • Documented success leading cross-functional teams, influencing without authority, and building alignment across global and U.S. stakeholders • Demonstrated people leadership, including recruitment, coaching, performance management, organizational development, and cultivation of future regulatory leaders • Excellent written and verbal communication skills • Strong judgment, integrity, collaboration, negotiation, conflict-resolution, and prioritization skills • Experience with Microsoft Office suite • Veeva regulatory publishing • PowerPoint presentation authoring and presentation • Business travel availability of 10–20% as required

🏖️ Benefícios

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Equal opportunity employer and reasonable accommodation support