Senior Regulatory Affairs Program Manager

Benefits

Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. Position Summary The Senior Regulatory Affairs Program Manager leads complex cross-functional regulatory initiatives from strategy through execution, ensuring products meet global regulatory requirements and are delivered in alignment with business objectives and launch timelines. This role partners closely with R&D, Clinical, CMC, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission activities and timelines, and support successful product approvals and lifecycle management worldwide. The position also serves as a key regulatory liaison, driving cross-functional alignment, proactive risk management, and regulatory excellence across the organization. Essential Functions Lead the design, planning, and execution of complex, cross-functional regulatory programs and strategic initiatives, establishing integrated project plans, timelines, milestones, deliverables, resource allocation, and proactive risk-mitigation strategies to ensure successful outcomes. Drive cross-functional collaboration across Regulatory Affairs, Quality, Clinical, R&D, Operations, Manufacturing, and Commercial teams to ensure alignment with global regulatory strategy, business priorities, and product development objectives. Provide program leadership and governance oversight for regulatory initiatives, including tracking key milestones, managing dependencies, escalating critical issues, and delivering concise status updates and strategic recommendations to executive leadership and external partners. Author, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, regulatory processes, and standardized templates to ensure consistency, inspection readiness, and adherence to applicable regulatory requirements. Mentor and provide guidance to junior team members and cross-functional partners on regulatory processes, project execution, and compliance expectations to strengthen organizational capabilities. Support regulatory inspections, audits, and health authority interactions by coordinating responses, preparing documentation, and ensuring timely follow-through on commitments and corrective actions. Lead and contribute to special projects, business-critical initiatives, and cross-functional assignments that support organizational objectives, drive innovation, and provide leadership development opportunities. Education & Experience Bachelor's degree in sciences, business, project management or a related field with 8+ years of relevant progressive experience required 5+ years in leadership preferred. 6+ years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred. 5+ years managing complex, multi‑regional regulatory programs is preferred. Knowledge, Skills, & Abilities Working knowledge of FDA regulations and other applicable global health authority requirements; experience supporting regulatory submissions and compliance activities preferred. Demonstrated ability to collaborate effectively with cross-functional teams, manage multiple priorities, and deliver projects within established timelines. Strong written and verbal communication skills, with the ability to clearly communicate regulatory requirements and project updates to diverse stakeholders. Strong analytical, organizational, and problem-solving skills with attention to detail and the ability to identify and mitigate potential risks. Proficiency with Microsoft Office Suite and project management tools and platforms (e.g., Monday.com); including task tracking, workflow management, timeline coordination, and team collaboration. Experience with regulat