ImmunityBio, Inc. · 22 hours ago
Regulatory Affairs Program Manager
Summit, NJ
Full-time
Onsite
Senior Level
$141K/yr - $157K/yr
7+ years expImmunityBio, Inc. is a biotechnology company focused on developing therapies to strengthen the immune system against cancer and infectious diseases. The Regulatory Affairs Program Manager will lead cross-functional regulatory projects, ensuring compliance with global regulatory requirements and managing timelines for product approvals.
Health CareHealth DiagnosticsTherapeutics
Responsibilities
Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies
Function 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
Qualification
Required
Bachelor's degree in sciences, business, project management or a related field with 7+ years of relevant progressive experience is required
5+ 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
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
Preferred
5+ 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
Benefits
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.
Company
ImmunityBio, Inc.
ImmunityBio, Inc.
501-1000 employees
H1B Sponsorship
ImmunityBio, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (4)
2023 (6)
2022 (7)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.36BKey Investors
Oberland CapitalNantCapitalPatrick Soon-Shiong
2025-07-25Post Ipo Equity· $80M
2025-04-08Post Ipo Equity· $75M
2024-12-11Post Ipo Equity· $100M
Leadership Team
Enrique Diloné
Chief Technology Officer
Leonard Sender
COO
Recent News
Los Angeles Business Journal
2025-12-24
Company data provided by crunchbase