BrainChild Bio is seeking a Director, Regulatory Affairs, to lead and execute the regulatory strategy for our CAR T programs. This role will serve as BrainChild Bio’s primary regulatory representative, responsible for guiding regulatory activities across preclinical, clinical, and manufacturing stages, while partnering closely with internal teams and external partners.
The Director will work cross-functionally with Clinical, CMC, Quality, and Patient Operations to plan and manage regulatory submissions, including INDs, IND amendments, and meeting packages. Responsibilities include developing regulatory strategies that support innovative CAR T development, preparing for and participating in FDA and ex-US health authority interactions, and ensuring documentation and filings are complete, accurate, and timely.
The ideal candidate brings substantial experience in Regulatory Affairs within a clinical-stage biotech, strong working knowledge of FDA regulations for cell and gene therapy products, and the ability to operate both strategically and hands-on. We’re seeking a collaborative, detail-oriented leader who thrives in a fast-moving environment and is motivated by bringing transformative therapies to patients.