Executive Director, Global Regulatory Lead

🕒 Abril 30

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Perspective Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2023

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $400.000 Grant em 2024-02

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Perspective Therapeutics é uma empresa de biotecnologia que se concentra no desenvolvimento de tratamentos inovadores para o câncer por meio de uma classe única de teranósticos. Suas tecnologias proprietárias permitem o direcionamento específico de tumores para tratamento, minimizando a toxicidade para tecidos saudáveis. Ao utilizar radiação, radiofármacos e tecnologias avançadas de imagem, a empresa busca melhorar a eficácia do tratamento e proporcionar melhores resultados para os pacientes com câncer.

Descrição

• Provide strategic regulatory leadership across radiopharmaceutical clinical development programs • Develop and execute global regulatory strategies • Lead global regulatory submissions in support of clinical development, product registrations, and lifecycle management activities • Translate complex and evolving global regulatory requirements into clear, actionable strategies • Ensure regulatory alignment across functions and support the successful advancement of radiopharmaceutical programs from early development through commercialization

🎯 Requisitos

• Bachelor’s degree in a scientific or life sciences discipline required; advanced degree (M.S. or Ph.D.) in biology, chemistry, pharmaceutical sciences, engineering, or a related field strongly preferred • Regulatory Affairs Certification (RAC) is a plus • Minimum of 10 years of progressive Regulatory Affairs experience within oncology, specialty therapeutics, and/or complex modalities, with demonstrated regulatory leadership and successful global development outcomes • Experience supporting radiopharmaceutical, oncology, or other complex drug modalities, with a strong understanding of modality‑specific regulatory considerations • Proven track record of leading major global regulatory submissions and approvals, including INDs, CTAs, and marketing applications, for clinical‑stage and/or commercial products • Extensive experience engaging with global health authorities (e.g., FDA, EMA, and other international agencies)

🏖️ Benefícios

• Remote, home-based position • Ability to sit for extended periods of time while working at a computer and participating in virtual meetings • Ability to use standard office equipment, including a computer, phone, and video conferencing tools