Regulatory Affairs Program Manager

ImmunityBio, Inc.-posted 3 days ago
Full-time • Mid Level
Onsite • Summit, NJ
501-1,000 employees
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The Regulatory Affairs Program Manager leads cross‑functional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and are launched on schedule. 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.
  • 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.
  • 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.
  • 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.
  • 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
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