ImmunityBio
Regulatory Affairs Program Manager
Summit, NJ
Sponsorship not specifiedDetected 30 days ago
Project ManagementFDA RegulatoryMedical DevicesLeadershipCommunicationMicrosoft OfficeRegulatory Affairs
About the role
- Coordinate cross‑functional project teams, ensuring alignment with regulatory objectives and strategy.
- Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards.
- Assess impact on products/processes and communicate findings.
Responsibilities
- 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.
- 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.
- 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.
- Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies.
- Identify risks early, develop mitigation plans, and resolve issues that could impact timelines or approvals.
- Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.
- Track and report program status to senior leadership and external partners.
- Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
Requirements
- Bachelor's degree in sciences, business, project management or a related field with 5+ years of relevant progressive experience is required.
- Proficiency with MS Office suites and project management tools.
Nice to have
- 3+ years managing complex, multi‑regional regulatory programs is preferred.
Skills
- Knowledge, Skills, & Abilities
- Excellent written and oral communication skills.
Compensation
- The annual base pay range for this position is below.
- $141,300 (entry-level qualifications) to $157,000 (highly experienced) annually
Benefits
- 4+ years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred.
Visa & Work Authorization
- 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
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.