Regulatory Affairs Program Manager
ImmunityBio, Inc.
June 27, 2026
On-site
Summit, NJ
Corporate Functions
Position Summary
The Regulatory Affairs Program Manager leads cross-functional regulatory projects from strategy through execution to ensure products meet global regulatory requirements and are launched on schedule.
Essential Functions
- Design, plan, and manage cross-functional and ongoing regulatory programs (schedules, milestones, deliverables, resources, risk mitigation).
- Serve as Regulatory Affairs point of contact; translate regulatory requirements into actionable objectives.
- Coordinate cross-functional project teams; track/report program status to senior leadership and external partners.
- Conduct regulatory intelligence; assess impact of laws/guidance/standards and communicate findings.
- Identify risks early; develop mitigation plans and resolve issues impacting timelines/approvals.
- Foster continuous improvement and regulatory excellence.
- Create/edit/adhere to SOPs, improve processes, and standardize templates.
- Perform ad-hoc/cross-functional projects as assigned.
Education & Experience
- Bachelor’s degree (sciences/business/project management or related) with 5+ years relevant progressive experience (required).
- 4+ years regulatory affairs experience in pharma/biologics/medical devices (preferred).
- 3+ years managing complex, multi-regional regulatory programs (preferred).
Knowledge, Skills, & Abilities
- Knowledge of FDA and other major health-authority requirements (plus).
- Ability to work cross-functionally, manage budgets, and deliver on schedule.
- Excellent written/oral communication; strong analytical/problem-solving.
- Proficiency with MS Office and project management tools.
On-site / Schedule
- On-site; Monday–Friday, standard business hours (flexibility with manager approval).
- Mobility required; lift/carry up to 30 lbs.
Benefits
- Discretionary bonus and equity award.
- Base pay range: $141,300–$157,000 annually.
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.
The Regulatory Affairs Program Manager leads cross-functional regulatory projects from strategy through execution to ensure products meet global regulatory requirements and are launched on schedule.
Essential Functions
- Design, plan, and manage cross-functional and ongoing regulatory programs (schedules, milestones, deliverables, resources, risk mitigation).
- Serve as Regulatory Affairs point of contact; translate regulatory requirements into actionable objectives.
- Coordinate cross-functional project teams; track/report program status to senior leadership and external partners.
- Conduct regulatory intelligence; assess impact of laws/guidance/standards and communicate findings.
- Identify risks early; develop mitigation plans and resolve issues impacting timelines/approvals.
- Foster continuous improvement and regulatory excellence.
- Create/edit/adhere to SOPs, improve processes, and standardize templates.
- Perform ad-hoc/cross-functional projects as assigned.
Education & Experience
- Bachelor’s degree (sciences/business/project management or related) with 5+ years relevant progressive experience (required).
- 4+ years regulatory affairs experience in pharma/biologics/medical devices (preferred).
- 3+ years managing complex, multi-regional regulatory programs (preferred).
Knowledge, Skills, & Abilities
- Knowledge of FDA and other major health-authority requirements (plus).
- Ability to work cross-functionally, manage budgets, and deliver on schedule.
- Excellent written/oral communication; strong analytical/problem-solving.
- Proficiency with MS Office and project management tools.
On-site / Schedule
- On-site; Monday–Friday, standard business hours (flexibility with manager approval).
- Mobility required; lift/carry up to 30 lbs.
Benefits
- Discretionary bonus and equity award.
- Base pay range: $141,300–$157,000 annually.
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.