Senior Regulatory Affairs Program Manager
ImmunityBio, Inc.
9 days ago
On-site
Summit, NJ
Corporate Functions
Position Summary
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. Partners with R&D, Clinical, CMC, Manufacturing, and Commercial; serves as a key regulatory liaison.
Essential Functions
- Lead design, planning, and execution of complex cross-functional regulatory programs (plans, timelines, milestones, deliverables, resources, risk mitigation).
- Drive cross-functional collaboration (Regulatory Affairs, Quality, Clinical, R&D, Operations, Manufacturing, Commercial).
- Provide program leadership/governance: milestone tracking, dependency management, escalation, and executive/external status updates.
- Author/revise/maintain SOPs, work instructions, regulatory processes, and templates.
- Mentor junior team members and cross-functional partners.
- Support regulatory inspections, audits, and health authority interactions (responses, documentation, commitments/corrective actions).
- Lead/contribute to special projects and business-critical cross-functional initiatives.
Education & Experience
- Bachelor’s degree in sciences/business/project management or related field + 8+ years relevant progressive experience (required)
- 5+ years leadership (preferred)
- 6+ years regulatory affairs in pharma/biologics/medical device (preferred)
- 5+ years managing complex, multi-regional regulatory programs (preferred)
Knowledge, Skills, & Abilities
- FDA and other global health authority requirements; regulatory submissions/compliance experience (preferred)
- Strong collaboration, multitasking, communication, analytical/problem-solving, and risk mitigation
- Microsoft Office + project tools (e.g., Monday.com); document/regulatory systems a plus
- Independent, accurate, fast-paced
- Continuous improvement and compliance focus
Benefits (eligible employees)
- Discretionary bonus and equity; Medical, Dental, Vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSAs; 401(k) match; 529; PTO (11 holidays) / Unlimited PTO for exempt; vacation/personal/cultural days for non-exempt
Application Instructions
- Application window closes 60 days from posting (or sooner if filled/closed).
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. Partners with R&D, Clinical, CMC, Manufacturing, and Commercial; serves as a key regulatory liaison.
Essential Functions
- Lead design, planning, and execution of complex cross-functional regulatory programs (plans, timelines, milestones, deliverables, resources, risk mitigation).
- Drive cross-functional collaboration (Regulatory Affairs, Quality, Clinical, R&D, Operations, Manufacturing, Commercial).
- Provide program leadership/governance: milestone tracking, dependency management, escalation, and executive/external status updates.
- Author/revise/maintain SOPs, work instructions, regulatory processes, and templates.
- Mentor junior team members and cross-functional partners.
- Support regulatory inspections, audits, and health authority interactions (responses, documentation, commitments/corrective actions).
- Lead/contribute to special projects and business-critical cross-functional initiatives.
Education & Experience
- Bachelor’s degree in sciences/business/project management or related field + 8+ years relevant progressive experience (required)
- 5+ years leadership (preferred)
- 6+ years regulatory affairs in pharma/biologics/medical device (preferred)
- 5+ years managing complex, multi-regional regulatory programs (preferred)
Knowledge, Skills, & Abilities
- FDA and other global health authority requirements; regulatory submissions/compliance experience (preferred)
- Strong collaboration, multitasking, communication, analytical/problem-solving, and risk mitigation
- Microsoft Office + project tools (e.g., Monday.com); document/regulatory systems a plus
- Independent, accurate, fast-paced
- Continuous improvement and compliance focus
Benefits (eligible employees)
- Discretionary bonus and equity; Medical, Dental, Vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSAs; 401(k) match; 529; PTO (11 holidays) / Unlimited PTO for exempt; vacation/personal/cultural days for non-exempt
Application Instructions
- Application window closes 60 days from posting (or sooner if filled/closed).