Specialist II, Regulatory Lifecycle Maintenance
ImmunityBio, Inc.
17 days ago
On-site
Summit, NJ
Corporate Functions
Position Summary
Specialist II, Regulatory Lifecycle Maintenance: Contribute to development and maintenance of global clinical documentation for investigational and marketed products; prepare regulatory dossiers in eCTD format; support clinical program management and clinical submission documentation (including clinical reports and summaries).
Essential Functions
- Review clinical data/reports/summaries for protocol, SAP, monitoring, and data management compliance.
- Support design, central monitoring, and reporting for IBRX or CRO clinical studies.
- Draft written summaries for INDs, NDAs, and BLAs.
- Prepare/review documentation (Investigator’s Brochures, protocols, Clinical Study Reports, annual reports, DSURs, clinicaltrials.gov entries, etc.).
- Ensure documents are labeled, dated, and stored per policies and regulatory requirements.
- Ensure compliance with BLA/MAA/IND/CTA submission and reporting requirements (U.S. and ex-U.S. authorities).
- Review submission packages (version verification, link checking) and coordinate with publishing.
- Maintain records in tracking systems/databases; create/maintain project plans.
- Participate in cross-functional teams; serve as a trainer for RA SOPs/templates.
- Perform ad-hoc cross-functional duties as needed.
Education & Experience (Required/Preferred)
- BS life sciences (or related) + 3+ years regulatory clinical science experience OR MS + 2+ years.
- Preferred: 2+ years clinical programs in pharma/biotech; eCTD clinical module submission experience; familiarity with HAI information requests and international regulatory submissions.
Knowledge/Skills/Abilities (Required)
- Health authority clinical guidance knowledge; GCP and regulatory requirements.
- Strong attention to detail; clinical documentation/terminology expertise.
- Deadline-driven, adaptable; strong written/oral communication and organizational skills.
Benefits (If Eligible)
Medical, Dental, Vision; EAP; company paid/voluntary life/AD&D, STD/LTD; FSA (health/dependent care); 401(k) match; 529; PTO (11 holidays) and unlimited PTO (exempt) / vacation & health/personal days (non-exempt).
Application Instructions
Application window anticipated to close 60 days from posting (or sooner if filled/closed).
Specialist II, Regulatory Lifecycle Maintenance: Contribute to development and maintenance of global clinical documentation for investigational and marketed products; prepare regulatory dossiers in eCTD format; support clinical program management and clinical submission documentation (including clinical reports and summaries).
Essential Functions
- Review clinical data/reports/summaries for protocol, SAP, monitoring, and data management compliance.
- Support design, central monitoring, and reporting for IBRX or CRO clinical studies.
- Draft written summaries for INDs, NDAs, and BLAs.
- Prepare/review documentation (Investigator’s Brochures, protocols, Clinical Study Reports, annual reports, DSURs, clinicaltrials.gov entries, etc.).
- Ensure documents are labeled, dated, and stored per policies and regulatory requirements.
- Ensure compliance with BLA/MAA/IND/CTA submission and reporting requirements (U.S. and ex-U.S. authorities).
- Review submission packages (version verification, link checking) and coordinate with publishing.
- Maintain records in tracking systems/databases; create/maintain project plans.
- Participate in cross-functional teams; serve as a trainer for RA SOPs/templates.
- Perform ad-hoc cross-functional duties as needed.
Education & Experience (Required/Preferred)
- BS life sciences (or related) + 3+ years regulatory clinical science experience OR MS + 2+ years.
- Preferred: 2+ years clinical programs in pharma/biotech; eCTD clinical module submission experience; familiarity with HAI information requests and international regulatory submissions.
Knowledge/Skills/Abilities (Required)
- Health authority clinical guidance knowledge; GCP and regulatory requirements.
- Strong attention to detail; clinical documentation/terminology expertise.
- Deadline-driven, adaptable; strong written/oral communication and organizational skills.
Benefits (If Eligible)
Medical, Dental, Vision; EAP; company paid/voluntary life/AD&D, STD/LTD; FSA (health/dependent care); 401(k) match; 529; PTO (11 holidays) and unlimited PTO (exempt) / vacation & health/personal days (non-exempt).
Application Instructions
Application window anticipated to close 60 days from posting (or sooner if filled/closed).