Associate Director – Regulatory Affairs

🔥 7 horas atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $200.000 - $240.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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GondolaBio

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2024

🏥 Saúde

💼 Consultoria

🏭 Manufatura

💰 $300.000.000 Venture Round - GondolaBio em 2024-08

Healthcare • Consulting • Manufacturing

A GondolaBio é uma empresa biofarmacêutica em estágio clínico lançada em 2024 e afiliada à BridgeBio Pharma, focada no desenvolvimento de terapias revolucionárias para pacientes com doenças genéticas. A empresa adota uma abordagem enxuta e descentralizada para acelerar a pesquisa e o desenvolvimento em estágio inicial através de múltiplas modalidades (incluindo pequenas moléculas e terapias com oligonucleotídeos) e está construindo um pipeline diversificado visando condições genéticas raras e pouco atendidas, como EPP/XLP, com seu programa principal PORT-77. A GondolaBio coloca as necessidades dos pacientes em primeiro lugar e busca levar tratamentos que modifiquem doenças de forma mais rápida para populações que não possuem terapias aprovadas.

Descrição

• Serve as the global regulatory lead for assigned development programs • Define stage-appropriate regulatory strategies and development pathways • Develop regulatory strategy for rare disease and accelerated development programs • Prepare orphan designation applications and support expedited development pathways • Partner with Clinical Development, Translational Sciences, Nonclinical, CMC, other functional teams, and CROs • Integrate regulatory considerations into development planning and key program decisions • Provide regulatory input on study design, translational biomarkers, dose selection, and first-in-human safety considerations • Provide guidance for efficient decision-making while balancing development speed, scientific rigor, and program optionality • Lead preparation for and interactions with global health authorities • Develop briefing documents, meeting strategies, and written correspondence • Lead and contribute to regulatory submissions, including INDs, CTAs, amendments, annual reports, and other filings • Monitor evolving regulatory guidance and industry trends • Evaluate regional regulatory requirements and opportunities to support global development efforts

🎯 Requisitos

• Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent) preferred • Associate Director: 7+ years of pharmaceutical/biotechnology industry experience, including at least 6 years of regulatory experience • Director: 10+ years of pharmaceutical/biotechnology industry experience, including at least 8 years of regulatory experience • Demonstrated record of regulatory success, including leading and supporting IND-stage programs through key regulatory milestones • Experience with rare diseases and familiarity with accelerated or expedited regulatory pathways • Proven track record leading and supporting interactions with regulatory authorities, including briefing documents, meetings, and written responses • Strong understanding of early clinical development, translational biomarkers, and first-in-human safety considerations • Strong cross-functional leadership and written and verbal communication skills • Familiarity with multiple therapeutic modalities, including oligonucleotides and small molecules • Ability to communicate regulatory risks, opportunities, and development tradeoffs • Willingness and ability to operate with limited precedent and incomplete data while maintaining regulatory credibility

🏖️ Benefícios

• Patient Days • Culture inspired by company values • Decentralized operating model with decision-making authority close to the science • Career ownership and development opportunities • Collaborative, fast-paced, data-driven environment • Access to learning and development resources • Robust and market-competitive health, welfare, and retirement programs • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple GondolaBio programs across multiple therapeutic areas

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