Associate Director / Director, Regulatory Affairs

About GondolaBio

GondolaBio 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.

Who You Are

You 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.

You 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.

Key Responsibilities

• 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.