Senior Director, Regulatory Affairs Lead in Menlo Park, California at Orca Bio

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.

• 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.