ImmunityBio
Specialist III, Regulatory Lifecycle Maintenance
Summit, NJ · Mid
Sponsorship not specifiedDetected 30 days ago
StatisticsClinical TrialsClinical ResearchResearchCommunicationOrganizational Skills
About the role
- The Specialist III, Regulatory Lifecycle Maintenance is responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assists with the preparation of dossiers in eCTD format.
- Review, edit and approve all final submissions to Health Authorities.
- Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan.
Responsibilities
- ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.
- Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow.
- Provide support and training to others in the preparation, analysis, and documentation of studies.
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
- Assist in daily operations outside of essential BLAs and provide regulatory input on day-to-day issues and provide regulatory documents to other departments.
- Draft and review essential BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing, and reconciliation.
Requirements
- Bachelor's degree in life sciences or a related field required
- 5+ years of relevant regulatory clinical Science experience is required, or
- Master's degree in life sciences or a related field required
- 3+ years of relevant regulatory clinical Science experience is required
- Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
- Strong knowledge of clinical documentation
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
Nice to have
- Experience in the preparation of the submission of clinical modules in eCTD format is preferred
- Familiarization with regulatory submissions internationally is preferred.
Skills
- Knowledge, Skills, & Abilities
- Strong organizational skills, written and oral communication skills, and attention to detail
Compensation
- Prepare or review documents including investigator brochures, protocols, clinical study reports, annual reports, DSURs, PAERs, clinicaltrials.gov entries, and other lifecycle maintenance documents.
Benefits
- Compile, organize, and catalogue essential regulatory documents on all active clinical studies to maintain compliance with Health Authorities.
Visa & Work Authorization
- race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.