Associate Director – Regulatory Affairs

🕒 6 dias atrás

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GondolaBio

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2024

🧬 Biotecnologia

💊 Farmacêutico

💰 $300.000.000 Venture Round - GondolaBio em 2024-08

Biotechnology • Pharmaceuticals

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, defining stage-appropriate regulatory strategies and development pathways. • Develop regulatory strategy for rare disease and accelerated development programs, including orphan designation applications and expedited development pathways. • Partner closely with Clinical Development, Translational Sciences, Nonclinical, CMC, and other functional teams, including working with CROs as needed, to integrate regulatory considerations into development planning and key program decisions. • Provide strategic regulatory input on study design, translational biomarkers, dose selection, and first-in-human safety considerations. • Provide regulatory guidance to support efficient and informed decision-making while balancing development speed, scientific rigor, and long-term program optionality. • Lead preparation for and interactions with global health authorities, including briefing documents, meeting strategy, and written correspondence. • Lead and contribute directly to the planning, preparation, and submission of high-quality regulatory submissions (e.g., IND, CTA), amendments, annual reports, and other regulatory filings. • Maintain awareness of evolving regulatory guidance and industry trends that may impact development strategies. • Support global development efforts by evaluating regional regulatory requirements and opportunities.

🎯 Requisitos

• Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent) preferred. • For Associate Director, we expect 7+ years of pharmaceutical/biotechnology industry experience, at least 6 of which should be regulatory experience; for Director, we expect 10+ years of pharmaceutical/biotechnology industry experience, at least 8 of which should be regulatory experience. • Demonstrated record of regulatory success, including leading and supporting IND-stage programs through key regulatory milestones and supporting advancement through development. • 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 communication (written and verbal) skills.

🏖️ Benefícios

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak • An unyielding commitment to always putting patients first • A decentralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science • A place where you own the vision – both for your program and your own career path • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game • Access to learning and development resources to help you get in the best professional shape of your life • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time • Commitment to Diversity, Equity & Inclusion