Director, Regulatory Affairs
BrainChild BioSeattle, Washington, United States
Posted November 10, 2025
195000 - 210000 USD year
Full Time
About the Company
BrainChild Bio is a kids-first, clinical-stage biotechnology company specializing in CAR-T cell technology for central nervous system tumors. Focused on treating diffuse intrinsic pontine glioma (DIPG) in pediatrics and expanding to other brain tumors and metastases, the company aims to optimize CAR-T applications and advance therapies for both pediatric and adult patients.
Job Description
BrainChild Bio is seeking a Director, Regulatory Affairs, to lead and execute the regulatory strategy for our CAR T programs.
Requirements
- 10+ years of regulatory affairs experience
- Strong working knowledge of FDA regulations and guidance for CAR T and other cell therapy products, as well as global regulatory frameworks
- Demonstrated ability to develop strategic regulatory plans and execute them in a fast-paced clinical-stage biotech environment
- Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders
- Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies
