Senior Director, Regulatory Affairs Lead

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, 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 Chief Medical Officer 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 CMO, 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 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. The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.   Who we are   We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.   We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.   We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.   We maintain a start-up culture of camaraderie and leadership by example, regardless of title.   We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.   Notice to staffing firms   Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.