Director, Regulatory Affairs

An experienced Regulatory Affairs professional leads global regulatory strategies for late-phase clinical development of gene therapy products in autoimmune and degenerative diseases. The role involves managing complex submissions like INDs and BLAs, interfacing with regulatory agencies, and collaborating with cross-functional R&D teams. Based primarily at the South San Francisco headquarters, the position requires hands-on leadership to drive adherence to FDA, EMA, and ICH guidelines.