Associate Director, Health Authorities
ImmunityBio, Inc.
June 26, 2026
On-site
Summit, NJ
Corporate Functions
Associate Director, Health Authorities
Responsibilities:
- Lead and manage Health Authorities direct reports; hire, train, coach, and monitor performance.
- Review clinical data/reports/summaries for protocol, SAP, monitoring guidelines, data management plan, and trial documents.
- Provide input to clinical study design/reporting.
- Manage preparation of clinical sections for regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs, and other applications).
- Create/maintain health authorities project plans; support cross-functional study preparation/documentation.
- Lead external stakeholder engagement (CROs, regulatory consultants, SMEs/KOLs) and draft high-quality RFI responses.
- Prepare/assign responses to agency questions; assemble final submission packages.
- Train on Regulatory Affairs SOPs/processes/templates; oversee review, QC, and finalization of application modules.
- Monitor and apply regional/local health authority guidance; interpret updates to mitigate agency queries.
- Govern version control (repository, naming conventions, change tracking, module approvals).
- Develop/maintain product-development roadmaps; perform ad-hoc cross-functional duties.
Qualifications:
- BS life sciences/technical discipline + 10+ years; or MS + 8+ years; or PhD + 6+ years (progressive, relevant).
- Required: experience managing staff; eCTD clinical module preparation/submission; medical writing; organizing responses to health authority information requests.
- Preferred: regulatory submissions experience outside the US.
Skills/Abilities:
- Expert knowledge of health authority guidance, clinical research/GCP, regulatory requirements, and clinical documentation.
- Strong leadership, organizational, written/oral communication, attention to detail; ability to meet deadlines and manage ambiguity.
Location/Schedule: On-site in Summit, NJ; Mon–Fri standard business hours (flexible with approval).
Compensation/Benefits (as stated): Discretionary bonus and equity; annual base pay $185,000–$203,500; Medical/Dental/Vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSAs; 401(k) match; 529; PTO (incl. 11 holidays; Unlimited PTO for Exempt; Non-Exempt: vacation/health pay/personal/cultural days).
Application window: anticipated to close 60 days from posting or sooner if filled/closed.
Responsibilities:
- Lead and manage Health Authorities direct reports; hire, train, coach, and monitor performance.
- Review clinical data/reports/summaries for protocol, SAP, monitoring guidelines, data management plan, and trial documents.
- Provide input to clinical study design/reporting.
- Manage preparation of clinical sections for regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs, and other applications).
- Create/maintain health authorities project plans; support cross-functional study preparation/documentation.
- Lead external stakeholder engagement (CROs, regulatory consultants, SMEs/KOLs) and draft high-quality RFI responses.
- Prepare/assign responses to agency questions; assemble final submission packages.
- Train on Regulatory Affairs SOPs/processes/templates; oversee review, QC, and finalization of application modules.
- Monitor and apply regional/local health authority guidance; interpret updates to mitigate agency queries.
- Govern version control (repository, naming conventions, change tracking, module approvals).
- Develop/maintain product-development roadmaps; perform ad-hoc cross-functional duties.
Qualifications:
- BS life sciences/technical discipline + 10+ years; or MS + 8+ years; or PhD + 6+ years (progressive, relevant).
- Required: experience managing staff; eCTD clinical module preparation/submission; medical writing; organizing responses to health authority information requests.
- Preferred: regulatory submissions experience outside the US.
Skills/Abilities:
- Expert knowledge of health authority guidance, clinical research/GCP, regulatory requirements, and clinical documentation.
- Strong leadership, organizational, written/oral communication, attention to detail; ability to meet deadlines and manage ambiguity.
Location/Schedule: On-site in Summit, NJ; Mon–Fri standard business hours (flexible with approval).
Compensation/Benefits (as stated): Discretionary bonus and equity; annual base pay $185,000–$203,500; Medical/Dental/Vision; wellness programs; EAP; life/AD&D; short/long-term disability; FSAs; 401(k) match; 529; PTO (incl. 11 holidays; Unlimited PTO for Exempt; Non-Exempt: vacation/health pay/personal/cultural days).
Application window: anticipated to close 60 days from posting or sooner if filled/closed.