Regulatory Affairs Leader - Post-Approval for Cell Therapy

Orca Bio in Menlo Park, CA, seeks a Senior Director, Head of Regulatory Affairs to lead regulatory strategy and lifecycle management for a commercial-stage biotech. This role reports to the Chief Medical Officer and guides post-approval operations, while preparing for future indications and global expansion. You will collaborate with FDA/EMA, build and lead the Regulatory Affairs team, and provide clear recommendations to executive leadership on risks and opportunities.