Senior Director, Head of Regulatory Affairs

Menlo Park, CARegulatory Affairs – Regulatory Affairs /Regular, Full-Time Employee /On-site

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, Head of Regulatory Affairs is Orca Bio's functional Head of Regulatory Affairs, leading the Regulatory Affairs function and serving 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.

Essential Duties &

Key Responsibilities:

Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the C-Suite, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements — with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions.

Develop and recommend regulatory strategy in partnership with executive leadership, and own execution of agreed strategic priorities across the organization.

Lead near-term post-approval regulatory execution, including commercial-stage supplements and variations, annual reports and lifecycle maintenance submissions, labeling updates, and post-marketing commitments.

Provide ongoing compliance support for the commercialized product, including leading Regulatory Affairs review of labeling, promotional, advertising, and other commercial materials through the company's cross-functional review process.

Lead ongoing interactions and correspondence with the FDA, EMA, and other health authorities on routine and operational matters, while helping prepare for and participate in major strategic health-authority engagements; partner with Quality on inspections, regulatory commitments, and follow-up actions.

Lead the assessment of significant regulatory, policy, and health-authority issues, providing executive leadership with clear recommendations, risks, and proposed paths forward.

Partner closely with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams to execute regulatory deliverables supporting the commercialized product and broader pipeline, and maintain regulatory readiness for future development programs, new indications, global expansion, and other significant milestones.

Maintain and continuously improve regulatory affairs systems, trackers, and records to ensure accurate, audit-ready documentation of submissions and…