Senior Director, Regulatory Affairs

Job description

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. ### 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 commitments. - Lead and develop the Regulatory Affairs team, and proactively keep executive leadership informed on regulatory status, risks, and timelines, bringing forward clear recommendations that foster accountability and continuous improvement. ### Required Qualifications - Bachelor’s degree in life sciences or a related discipline required. - 10+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including deep U.S. regulatory experience and meaningful experience working with global health authorities such as the EMA. - Track record of participating in approval of a commercial-stage product strongly preferred; experience in hematology, oncology, cell therapy, or bone marrow transplant preferred. - Demonstrated success managing post-approval regulatory activities, including commercial-stage supplements, labeling changes, annual reports, and post-marketing commitments. - Working knowledge of drug development and commercialization requirements, including clinical trial requirements, CMC, manufacturing, quality, post-marketing surveillance, and promotional review. - Proven people leader with a track record of building, coaching, and developing high-performing teams. - Excellent written and verbal communication skills, with the ability to proactively engage and inform executive leadership and translate complex regulatory matters into clear, actionable recommendations; strong project management and organizational skills suited to a hands-on, detail-oriented, small commercial-stage biotech environment. ### Reporting Structure & Authority Leads the Regulatory Affairs function and team, with day-to-day decision-making authority for regulatory execution, submissions, lifecycle activities, and routine health-authority interactions. Significant regulatory strategy decisions and major agency positions are developed in partnership with, and approved by, executive leadership.