Senior Director, Global Regulatory Lead

🕒 Outubro 29

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 10%

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Perspective Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2023

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

💰 $400.000 Grant em 2024-02

Healthcare • Manufacturing • Biotechnology

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 and future commercial launches • Develop and execute global regulatory strategies and lead global regulatory submissions • Serve as the single point of accountability for global regulatory strategy for assigned development programs • Develop and maintain global regulatory roadmaps integrating clinical, CMC/radiochemistry, non-clinical, quality, manufacturing, companion diagnostic, and lifecycle considerations • Shape global regulatory pathways, including expedited programs, dose and regimen optimization, radiopharmaceutical guidance, and regulatory interactions • Drive regulatory strategy across initial approvals, post-marketing commitments, pediatric development, label expansion, and global market expansion • Lead, mentor, and develop Global Regulatory Affairs team members and provide matrix leadership • Oversee IND, CTA, CTIS, NDA, MAA, pediatric plan, amendment, and safety update submissions • Lead responses to global regulatory inquiries and health authority questions • Lead strategy, content development, and execution for global health authority interactions • Serve as senior regulatory representative and spokesperson for the company • Monitor global regulatory frameworks, emerging guidance, and precedent decisions • Translate regulatory intelligence into development, risk management, and portfolio decision-making • Ensure high-quality, consistent, and compliant regulatory documentation • Partner with Regulatory Operations on submission planning, publishing, tracking, lifecycle management, and archival • Oversee IMPD and CMC module alignment with clinical supply, radiochemistry, analytical methods, stability, and isotope lifecycle considerations • Provide strategic oversight of external regulatory consultants, CROs, and specialized vendors

🎯 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 • Experience supporting radiopharmaceutical, oncology, or other complex drug modalities • Track record leading major global regulatory submissions and approvals, including INDs, CTAs, and marketing applications • Extensive experience engaging with global health authorities, including FDA and EMA • Strong understanding of global regulatory requirements for oncology and complex therapeutic modalities • Broad knowledge of drug development, regulatory compliance, commercialization, and lifecycle management • Ability to lead, influence, and align cross-functional teams and senior stakeholders • Project and program leadership skills, including managing priorities, timelines, dependencies, and risks • Ability to travel for business as required, up to 20% • Ability to work regular business hours with flexibility across time zones • Strong attention to detail and accurate information management • Ability to work independently and effectively in a remote, collaborative, team-based setting • Willingness to complete required corporate, compliance, and systems training

🏖️ Benefícios

• Equal employment opportunities and anti-discrimination protections • Remote, home-based work arrangement • Flexibility to support meetings across time zones • Standard office equipment and video conferencing tools • Corporate, compliance, and systems training

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