Senior Director, Regulatory Affairs

Regulatory Affairs Regular, Full-Time Employee More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Position Summary: The Senior Director of Regulatory Affairs will lead the Regulatory Affairs function and serve as the company's primary regulatory subject-matter expert and advisor. The incumbent will assist the C-Suite to develop and prepare for regulatory strategy which should be agreed by the executive leadership. Significant strategy decisions and major agency positions remain subject to executive leadership approval. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves. The incumbent leads and develops the Regulatory Affairs team and is a clear, proactive communicator who keeps executive leadership informed, surfaces risks early, and brings forward well-reasoned recommendations.