Regulatory Affairs Program Manager

Job description

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 Regulatory Affairs Program Manager leads cross‑functional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and are launched on schedule. This role partners closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission timelines, and drive successful product approvals worldwide. Essential Functions Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies. Act as a Regulatory Affairs point of contact for internal teams, translating regulatory requirements into clear and actionable objectives. Coordinate cross‑functional project teams, ensuring alignment with regulatory objectives and strategy. Track and report program status to senior leadership and external partners. Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards. Assess impact on products/processes and communicate findings. Identify risks early, develop mitigation plans, and resolve issues that could impact timelines or approvals. Foster a culture of continuous improvement and regulatory excellence. Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor’s degree in sciences, business, project management or a related field with 5+ years of relevant progressive experience is required. 4+ years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred. 3+ years managing complex, multi‑regional regulatory programs is preferred. Knowledge, Skills, & Abilities Understanding and knowledge of FDA and other major health‑authority requirements, a plus. Proven ability to work with cross‑functional teams, manage budgets, and deliver on schedule. Excellent written and oral communication skills. Strong analytical and problem‑solving abilities. Proficiency with MS Office suites and project management tools. Working Environment / Physical Environment This position works on-site Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. Lift and carry materials weighing up to 30 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location. $141,300 (entry-level qualifications) to $157,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.