Associate Director – Regulatory Strategy, Clinical & Nonclinical

🕒 Julho 27

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $160.000 - $220.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 31%

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

Atsena Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

🏥 Saúde

💰 $150.000.000 Series C - Atsena Therapeutics em 2025-04

Biotechnology • Healthcare

A Atsena Therapeutics é uma empresa de terapia gênica em fase clínica, desenvolvendo tratamentos de primeira classe para doenças hereditárias da retina. Seu programa principal, ATSN-201, está em um ensaio clínico de Fase 3 para retinosquise ligada ao cromossomo X (XLRS); outros programas incluem ATSN-101 para LCA1 (ensaio pivotal planejado) e ativos em estágio inicial voltados para a Síndrome de Usher 1B e a doença de Stargardt. A Atsena utiliza plataformas de entrega baseadas em AAV proprietárias — notavelmente o capsídeo AAV. SPR de espalhamento lateral e uma tecnologia de vetor duplo — desenvolvidas para enfrentar desafios na entrega retiniana e possibilitar cargas gênicas maiores. A empresa foca no avanço de terapias gênicas oculares através do desenvolvimento clínico.

Descrição

• Lead global regulatory strategy and execution for gene therapy programs from early research through clinical development and commercialization • Develop and implement global regulatory strategies for gene therapy programs from preclinical through clinical development and commercialization • Provide regulatory guidance on nonclinical, clinical, and translational development plans • Identify regulatory risks and propose mitigation strategies to support program timelines • Contribute to overall product development strategy and lifecycle planning • Lead preparation and submission of global regulatory filings, including INTERACT and PreINDs, INDs and IND amendments, CTAs and IMPDs, orphan drug designation applications, Fast Track, RMAT, and other expedited program submissions • Ensure high-quality regulatory documentation aligned with agency expectations • Prepare regulatory briefing documents and support agency meetings • Serve as a subject matter expert for interactions with agencies including the FDA and EMA • Coordinate and author responses to health authority questions and information requests • Partner with Clinical Development, Clinical Operations, Nonclinical, and Quality teams • Serve as a regulatory representative on cross-functional program teams • Ensure alignment of development plans with global regulatory requirements • Monitor evolving regulations and guidance related to gene therapies and biologics • Interpret guidance documents and communicate regulatory expectations internally • Contribute to internal regulatory processes and best practices

🎯 Requisitos

• PhD, PharmD, MD or MS in life sciences, molecular biology, pharmacology, or related discipline • Direct experience with AAV, lentiviral, or other gene therapy platforms preferred • Experience with rare disease development programs preferred • Experience with global regulatory submissions including US and EU preferred • Prior participation in regulatory agency meetings preferred • Associate Director: 7–10 years of experience in regulatory affairs within biotech or pharmaceutical industry • Associate Director: Experience supporting INDs, CTAs, and early clinical development • Director: 10–15+ years of experience in regulatory affairs with demonstrated leadership of regulatory strategy for development programs • Director: Proven experience leading regulatory submissions and interactions with agencies • Strong understanding of regulatory pathways for biologics and gene therapy products • Experience with nonclinical regulatory requirements for biologics • Excellent regulatory writing and communication skills • Ability to lead cross-functional teams and influence program strategy • Strong project management and organizational skills • Strategic thinking and problem solving • Strong scientific and regulatory knowledge • Cross-functional leadership and collaboration • Clear communication and influence • Ability to work in a fast-paced, early-stage biotech environment