AD – Director, Regulatory Affairs – FSP Team

🕒 Setembro 23

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 10%

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

Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Develop and execute regulatory strategy for assigned development programs • Lead regulatory planning and execution, including pre-submission activities, dossier strategy, submission readiness, health authority review and lifecycle management • Coordinate cross-functional development and review of regulatory submissions • Work closely with Clinical, CMC, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, Quality, Commercial and other functions • Lead preparation of responses to assessment questions, including Day 120 and Day 180 review milestones • Develop regulatory strategies, briefing packages and meeting preparation for health authority interactions • Lead or support regulatory activities • Provide regulatory leadership for clinical trial activities conducted through CTIS, including initial applications, substantial modifications and ongoing maintenance • Identify and communicate emerging regulatory risks, opportunities and requirements • Translate regulatory issues into pragmatic recommendations and mitigation plans • Contribute to labeling, product information, Risk Management Plans and other registration or post-authorization activities • Represent Regulatory Affairs on development teams and governance forums • Contribute to broader global regulatory strategy • Build partnerships across functions and external stakeholders • Facilitate timely decisions and resolve complex regulatory issues through scientific evidence, regulatory judgment and constructive challenge • Maintain regulatory quality, compliance and integrity of decision-making

🎯 Requisitos

• Degree in life sciences, pharmacy, medicine or a related scientific discipline • Advanced degree preferred • Significant progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry • Strong expertise in European drug development and registration • Substantial involvement in regulatory strategy, dossier preparation, submission and health authority review • Practical experience preparing and coordinating responses to assessment questions and interacting with regulatory authorities • Strong knowledge of pharmaceutical legislation, procedures, ICH guidelines, GCP and applicable regulatory requirements • Ability to interpret complex scientific and regulatory information and translate it into clear, actionable recommendations • Strong communication, influencing, negotiation and project leadership skills • Ability to operate effectively across functions and organizational levels • Comfortable working independently and taking ownership of outcomes • Collaborative and solution-oriented approach, with intellectual curiosity, sound judgment and openness to alternative perspectives • Ability to balance speed and pragmatism with scientific rigor, regulatory compliance and high-quality execution

🏖️ Benefícios

• Fully remote work arrangement • Standard Monday–Friday work schedule • Domestic and international travel opportunities (approximately 10–20%, depending on program and business needs)