Head of Regulatory Affairs

🕒 Setembro 8

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

👻 Score fantasma 12%

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

ARTBIO

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏭 Manufatura

📦 Logística

🧬 Biotecnologia

💰 $90.000.000 Series A em 2023-12

Manufacturing • Logistics • Biotechnology

A ARTBIO é uma empresa de biotecnologia radiofarmacêutica em estágio clínico, focada no desenvolvimento de uma nova classe de terapias com radioligantes alfa (ART). Sua abordagem diferenciada, centrada no paciente, é baseada em um profundo conhecimento da biologia do câncer e na infraestrutura necessária para projetar, fabricar e distribuir suas terapias de forma eficaz.

Descrição

• Define and lead global regulatory strategy for ARTBIO’s clinical-stage radiopharmaceutical programs • Lead key regulatory submissions, including INDs, CTAs, and DMFs • Lead FDA and global health authority interactions, including meeting preparation, briefing packages, responses, and follow-up actions • Ensure compliance with regulatory requirements throughout the drug development lifecycle, including clinical trials and manufacturing • Proactively identify potential regulatory risks and develop mitigation strategies • Identify regulatory risks and advise executive leadership on timelines and decision points • Partner with Clinical, CMC, Quality, Nonclinical, Clinical Development and Operations, regulatory consultants, and external publishing partners to support timely, high-quality submissions • Serve as the primary point of contact for regulatory agencies and build strong relationships with key regulatory authorities • Monitor regulatory policy changes and provide practical guidance to internal teams on requirements, risks, and opportunities • Build regulatory capability through team leadership, mentoring, training, and strong cross-functional collaboration

🎯 Requisitos

• 15+ years of regulatory affairs experience in the biotech or pharmaceutical industries, with emphasis on drug development • In-depth knowledge of global regulatory requirements and guidelines, including FDA and EMA regulations and international regulatory frameworks • Proven track record of successful regulatory submissions, including INDs, NDAs, BLAs and MAAs • Experience leading regulatory affairs strategies for complex programs across multiple therapeutic areas • Strong understanding of drug development processes, CMC, quality, and clinical trial regulations • Demonstrated ability to navigate complex regulatory landscapes and anticipate and mitigate potential regulatory risks • Familiarity with radiopharmaceuticals is a plus • Advanced degree (JD, PhD, PharmD, MD or equivalent) in a scientific discipline is preferred • Proactive, detail-oriented, and eager to learn • Comfortable working in a fast-paced biotech environment • Team player who thrives on collaboration and cross-functional flexibility • Commitment to safety and continuous improvement

🏖️ Benefícios

• A unique chance to contribute to first-in-class cancer therapies • Exposure to both radiochemistry and CMC development in a dynamic biotech setting • Hands-on training and professional development opportunities • An international, collaborative, and supportive work culture • Competitive compensation and benefits