Specialist III, Regulatory Lifecycle Maintenance
ImmunityBio, Inc.
June 24, 2026
On-site
Summit, NJ
Corporate Functions
Position Summary
Specialist III, Regulatory Lifecycle Maintenance responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assisting with preparation of dossiers in eCTD format; ensures clinical trials conform to Health Authority requirements.
Essential Functions
- Prepare or review lifecycle maintenance documents (investigator brochures, protocols, clinical study reports, annual reports, DSURs, PAERs, ClinicalTrials.gov entries, etc.).
- Compile, organize, and catalogue essential regulatory documents for active clinical studies.
- Review, edit, and approve final submissions to Health Authorities.
- Provide regulatory input on day-to-day issues and regulatory documents to other departments.
- Review clinical data/reports/summaries for protocol, SAP, monitoring guidelines, and data management plan compliance.
- Assemble reporting for studies performed by IBRX or CROs.
- Draft regulatory submission summaries (INDs, NDAs, BLAs).
- Support and train others on preparation/analysis/documentation of studies.
- Draft/review BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing, and reconciliation.
- Perform ad-hoc/cross-functional duties as assigned.
Education & Experience
- Bachelor’s in life sciences/related field required; 5+ years relevant regulatory clinical science experience, OR
- Master’s in life sciences/related field required; 3+ years relevant regulatory clinical science experience.
- Preferred: eCTD clinical module submission preparation experience.
- Preferred: familiarity with Health Authority information request responses.
- Preferred: international regulatory submission experience.
Knowledge, Skills, & Abilities
- Knowledge of Health Authority clinical guidance/requirements.
- Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements.
- Strong clinical documentation knowledge; strong organization, communication, attention to detail.
- Ability to meet deadlines and adapt to changing priorities.
Benefits (as stated)
- Discretionary bonus and equity award.
- Medical, Dental and Vision Plan Options; Wellness programs; EAP; Life/AD&D; Short-Term/Long-Term Disability; Flexible Spending Accounts; 401(k) match; 529; Paid Time Off (11 holidays); Unlimited PTO for exempt; Non-exempt vacation/health pay/personal/cultural days.
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.
Specialist III, Regulatory Lifecycle Maintenance responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assisting with preparation of dossiers in eCTD format; ensures clinical trials conform to Health Authority requirements.
Essential Functions
- Prepare or review lifecycle maintenance documents (investigator brochures, protocols, clinical study reports, annual reports, DSURs, PAERs, ClinicalTrials.gov entries, etc.).
- Compile, organize, and catalogue essential regulatory documents for active clinical studies.
- Review, edit, and approve final submissions to Health Authorities.
- Provide regulatory input on day-to-day issues and regulatory documents to other departments.
- Review clinical data/reports/summaries for protocol, SAP, monitoring guidelines, and data management plan compliance.
- Assemble reporting for studies performed by IBRX or CROs.
- Draft regulatory submission summaries (INDs, NDAs, BLAs).
- Support and train others on preparation/analysis/documentation of studies.
- Draft/review BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing, and reconciliation.
- Perform ad-hoc/cross-functional duties as assigned.
Education & Experience
- Bachelor’s in life sciences/related field required; 5+ years relevant regulatory clinical science experience, OR
- Master’s in life sciences/related field required; 3+ years relevant regulatory clinical science experience.
- Preferred: eCTD clinical module submission preparation experience.
- Preferred: familiarity with Health Authority information request responses.
- Preferred: international regulatory submission experience.
Knowledge, Skills, & Abilities
- Knowledge of Health Authority clinical guidance/requirements.
- Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements.
- Strong clinical documentation knowledge; strong organization, communication, attention to detail.
- Ability to meet deadlines and adapt to changing priorities.
Benefits (as stated)
- Discretionary bonus and equity award.
- Medical, Dental and Vision Plan Options; Wellness programs; EAP; Life/AD&D; Short-Term/Long-Term Disability; Flexible Spending Accounts; 401(k) match; 529; Paid Time Off (11 holidays); Unlimited PTO for exempt; Non-exempt vacation/health pay/personal/cultural days.
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.