Senior Regulatory Affairs Program Manager

ImmunityBio•Summit, NJ

15h•Onsite

About The Position

The Senior Regulatory Affairs Program Manager leads complex cross-functional regulatory initiatives from strategy through execution, ensuring products meet global regulatory requirements and are delivered in alignment with business objectives and launch timelines. This role partners closely with R&D, Clinical, CMC, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission activities and timelines, and support successful product approvals and lifecycle management worldwide. The position also serves as a key regulatory liaison, driving cross-functional alignment, proactive risk management, and regulatory excellence across the organization.

Requirements

Bachelor’s degree in sciences, business, project management or a related field with 8+ years of relevant progressive experience required
5+ years in leadership preferred.
6+ years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred.
5+ years managing complex, multi‑regional regulatory programs is preferred.
Working knowledge of FDA regulations and other applicable global health authority requirements; experience supporting regulatory submissions and compliance activities preferred.
Demonstrated ability to collaborate effectively with cross-functional teams, manage multiple priorities, and deliver projects within established timelines.
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); including task tracking, workflow management, timeline coordination, and team collaboration.
Ability to work independently in a fast-paced environment while maintaining a high level of accuracy, accountability, and professionalism.
Commitment to continuous improvement, process efficiency, and maintaining high standards of regulatory compliance.

Nice To Haves

Experience with regulatory systems or document management platforms is a plus.

Responsibilities

Lead the design, planning, and execution of complex, cross-functional regulatory programs and strategic initiatives, establishing integrated project plans, timelines, milestones, deliverables, resource allocation, and proactive risk-mitigation strategies to ensure successful outcomes.
Drive cross-functional collaboration across Regulatory Affairs, Quality, Clinical, R&D, Operations, Manufacturing, and Commercial teams to ensure alignment with global regulatory strategy, business priorities, and product development objectives.
Provide program leadership and governance oversight for regulatory initiatives, including tracking key milestones, managing dependencies, escalating critical issues, and delivering concise status updates and strategic recommendations to executive leadership and external partners.
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.
Mentor and provide guidance to junior team members and cross-functional partners on regulatory processes, project execution, and compliance expectations to strengthen organizational capabilities.
Support regulatory inspections, audits, and health authority interactions by coordinating responses, preparing documentation, and ensuring timely follow-through on commitments and corrective actions.
Lead and contribute to special projects, business-critical initiatives, and cross-functional assignments that support organizational objectives, drive innovation, and provide leadership development opportunities.

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