NantHealth · 3 weeks ago
Regulatory Affairs Program Manager
Summit, NJ
Full-time
Onsite
Senior Level
$141K/yr - $157K/yr
7+ years expImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing innovative cell and immunotherapy products to enhance the human immune system's ability to combat cancer. The Regulatory Affairs Program Manager will lead cross-functional regulatory projects, ensuring compliance with global regulatory requirements and timely product launches by collaborating with various internal teams.
Health CareHealth DiagnosticsHospitalMedicalTherapeutics
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
Company
NantHealth
NantHealth is a healthcare company providing an evidence-based platform for healthcare diagnostics. It is a sub-organization of NantWorks.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$980.2MKey Investors
VeradigmCelgeneVerizon Ventures
2023-03-06Post Ipo Debt· $22.5M
2021-05-06Post Ipo Debt· $147.5M
2016-12-01Post Ipo Debt· $102.7M
Leadership Team
Lauren Schiegg
Chief Operating Officer
Ron Louks
Chief Operating Officer
Recent News
globalventuring.com
2025-10-27
Company data provided by crunchbase