Senior Director, Regulatory Affairs

🕒 4 dias atrás

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

⏰ Tempo Integral

🟠 Sênior

🚔 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.

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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

• Serve as the point of contact for Health Authorities • Translate program regulatory strategy into interaction plans, submission plans, timelines, and cross-functional deliverables for clinical-stage radiopharmaceutical programs • Lead preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissions • Schedule and coordinate meeting rehearsals before Health Authority interactions • Finalize meeting minutes with Health Authorities, responses to information requests, and follow-up actions • Oversee publishing and submissions • Partner with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other contributors to develop content, resolve data gaps, and maintain an aligned submission narrative • Maintain records of correspondence, commitments, decisions, and submission history • Establish and maintain regulatory plans, workflows, submission calendars, trackers, and archives • Coordinate regulatory medical writing across functions and translate research and development data and strategy into clear, compliant regulatory communications and high-quality submission deliverables

🎯 Requisitos

• Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; an advanced degree is preferred • 12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry • Leadership in regulatory interaction deliverables supporting pre-IND to Phase 3 investigational-stage oncology programs • Strong knowledge of US FDA requirements and interaction processes • Proven track record coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requests • Hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors • Experience leading submission of New Drug Applications and Marketing Authorization Applications is helpful • Familiarity with radiopharmaceutical development is helpful • Clear, concise communication with strong scientific judgment and exceptional writing and editing skills • Highly organized, proactive, and detail-oriented, with disciplined follow-through on commitments and timelines • Comfortable working in a fast-paced biotech environment with evolving priorities and multiple stakeholders • Collaborative leadership and ability to align subject matter experts, challenge constructively, and drive decisions • Commitment to quality, compliance, and patient safety

🏖️ 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