ImmunityBio
Senior Regulatory Affairs Program Manager
Summit, NJ · Senior
Sponsorship not specifiedDetected 30 days ago
Project ManagementFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMicrosoft OfficeRegulatory Affairs
About the role
- The position also serves as a key regulatory liaison, driving cross-functional alignment, proactive risk management, and regulatory excellence across the organization.
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.
- 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.
- Lead and contribute to special projects, business-critical initiatives, and cross-functional assignments that support organizational objectives, drive innovation, and provide leadership development opportunities.
- Mentor and provide guidance to junior team members and cross-functional partners on regulatory processes, project execution, and compliance expectations to strengthen organizational capabilities.
Requirements
- Bachelor's degree in sciences, business, project management or a related field with 8+ years of relevant progressive experience required
- 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)
- Ability to work independently in a fast-paced environment while maintaining a high level of accuracy, accountability, and professionalism.
Nice to have
- 5+ years in leadership preferred.
- 5+ years managing complex, multi‑regional regulatory programs is preferred.
- Experience with regulatory systems or document management platforms is a plus.
Skills
- Knowledge, Skills, & Abilities
Compensation
- The annual base pay range for this position is below.
Benefits
- Support regulatory inspections, audits, and health authority interactions by coordinating responses, preparing documentation, and ensuring timely follow-through on commitments and corrective actions.
- 6+ 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.