Associate director / director, regulatory affairs

PpJob Type: Full-time /p h3Description /h3 pGondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. /p h3About GondolaBio /h3 pGondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. /p h3Who You Are /h3 pYou are an experienced regulatory affairs professional with expertise in early clinical development and a strong track record of advancing innovative therapies through key regulatory milestones. You are comfortable leading regulatory strategy for one or more development programs while partnering closely with cross-functional teams in a small, fast-moving biotech environment. /p pYou thrive at the intersection of science, clinical development, and regulatory execution, bringing a pragmatic, solutions-oriented mindset to navigating complex regulatory pathways, including those relevant to rare diseases and accelerated development. You are equally comfortable developing strategy and driving execution, ensuring that regulatory plans are aligned with program objectives and business priorities. /p h3Key Responsibilities /h3 ul liServe as the global regulatory lead for assigned development programs, defining stage-appropriate regulatory strategies and development pathways. /li liDevelop regulatory strategy for rare disease and accelerated development programs, including orphan designation applications and expedited development pathways. /li liPartner 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. /li liProvide strategic regulatory input on study design, translational biomarkers, dose selection, and first-in-human safety considerations. /li liProvide regulatory guidance to support efficient and informed decision-making while balancing development speed, scientific rigor, and long-term program optionality. /li liLead preparation for and interactions with global health authorities, including briefing documents, meeting strategy, and written correspondence. /li liLead 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. /li liMaintain awareness of evolving regulatory guidance and industry trends that may impact development strategies. /li liSupport global development efforts by evaluating regional regulatory requirements and opportunities. /li /ul h3Requirements /h3 h3Preferred Education Experience /h3 ul liAdvanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent) preferred. /li liFor 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. /li liDemonstrated record of regulatory success, including leading and supporting IND-stage programs through key regulatory milestones and supporting advancement through development. /li liExperience with rare diseases and familiarity with accelerated or expedited regulatory pathways. /li liProven track record leading and supporting interactions with regulatory authorities, including briefing documents, meetings, and written responses. /li liStrong understanding of early clinical development, translational biomarkers, and first-in-human safety considerations. /li liStrong cross-functional leadership and communication (written and verbal) skills. /li /ul h3Nice-to-Haves /h3 ul liFamiliarity with multiple therapeutic modalities, including oligonucleotides and small molecules. /li liAbility to communicate regulatory risks, opportunities, and development tradeoffs in support of program decision-making. /li liWillingness and ability to operate with limited precedent and incomplete data while maintaining regulatory credibility. /li /ul h3No matter your role at GondolaBio, successful team members are: /h3 ul liPatient Champions, who put patients first and uphold strict ethical standards /li liEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindset /li liTruth Seekers, who are detailed, rational, and humble problem solvers /li liIndividuals Who Inspire Excellence in themselves and those around them /li liHigh-quality executors, who execute against goals and milestones with quality, precision, and speed /li /ul h3What We Offer /h3 ul liPatient 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 /li liA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak /li liAn unyielding commitment to always putting patients first /li liA 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 /li liA place where you own the vision – both for your program and your own career path /li liA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game /li liAccess to learning and development resources to help you get in the best professional shape of your life /li liRobust and market-competitive compensation benefits package (Base, Performance Bonus, Equity, health, welfare retirement programs) /li liFlexible PTO /li liRapid career advancement for strong performers /li liPotential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time /li liCommitment to Diversity, Equity Inclusion /li /ul pThe base pay range for this position is $225,000 to $275,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered. /p pGondolaBio ServiceCo is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Employees of BridgeBio and all affiliated companies should work through their managers to inquire about and learn more about this role. /p /p #J-18808-Ljbffr