Specialist III, Regulatory Lifecycle Maintenance

Company Overview
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. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. 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. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.

Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary

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.  This role will provide a high level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements.

Essential Functions

• Prepare or review documents including investigator brochures, protocols, clinical study reports , annual reports, DSURs, PAERs, clinicaltrials.gov entries, and other lifecycle maintenance documents.
• Compile, organize, and catalogue essential regulatory documents on all active clinical studies to maintain compliance with Health Authorities.
• Review, edit and approve all final submissions to Health Authorities.
• Assist in daily operations outside of essential BLAs and provide regulatory input on day-to-day issues and provide regulatory documents to other departments.

• Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan.
• Assemble the reporting of clinical studies performed by IBRX or by CROs.
• Draft written summaries for regulatory submissions including but not limited to, INDs, NDAs, and BLAs.
• Provide support and training to others in the preparation, analysis, and documentation of studies.
• Draft and review essential BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing, and reconciliation.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

• 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
• Experience in the preparation of the submission of clinical modules in eCTD format is preferred
• Familiar with organizing responses to Health Authority information requests is preferred
• Familiarization with regulatory submissions internationally is preferred.

Knowledge, Skills, & Abilities

• Knowledge of Health Authority clinical guidance documents and requirements
• 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
• Strong organizational skills, written and oral communication skills, and attention to detail

Working Environment / Physical Environment

• This position works on-site in Summit, NJ.
•  The position may need to sit for long periods of time and use various computer programs.
• This desk-based role involves the close study of scientific and regulatory documents.
• They will work closely with scientific colleagues throughout the day, often on a project team basis.
• Lift and carry materials weighing up to 20 pounds.

This position is eligible for a