Associate/ Director, Regulatory Affairs

Company Background GondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Portal Therapeutics is the lead program in GondolaBio’s portfolio. Portal is developing a novel potential best-in-class therapy for erythropoietic protoporphyria, a severe genetic disease of the blood which results in extreme sensitivity to sunlight and liver damage.

Who You Are

• A regulatory affairs leader who owns global regulatory strategy and execution for Portal's program and drives the plans, timelines, and cross-functional coordination that turn that strategy into filings.
• Reporting to the Head of Regulatory Affairs, this role is both strategic and hands-on: you will lead health authority interactions, serve as the project manager for major submissions, and act as the regulatory voice on the program team.
• Prior ownership of an NDA or BLA is essential.