Specialist II, Regulatory Lifecycle Maintenance

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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 II, Regulatory Lifecycle Maintenance will contribute to the development and maintenance of global clinical for investigational and marketed products and contribute towards the preparation of dossiers in eCTD format. This position will support the organization in the management and conduct of clinical programs, clinical programs and preparation of documentation to support clinical submissions including the preparation of clinical reports and summaries, Essential Functions Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan. Contribute to the design, central monitoring, and reporting of clinical studies performed by IBRX or by CROs. Assist with written summaries for regulatory submissions including INDs, NDAs, and BLAs Contribute to the preparation or review of documents including Investigator's Brochures, protocols, Clinical Study Reports, annual reports, DSURs, clinicaltrials.gov entries, etc., Ensure that all documents are properly labeled, dated, and stored in accordance with company policies and regulatory requirements Ensure compliance with BLA, MAA, IND, and CTA, submission and reporting requirements with the U.S. and ex-U.S. Health Authorities Review submission packages including version verification, link checking, and coordination with the publishing group. Maintain accurate records of filed documents, including updating tracking systems and databases as needed Create and maintain project plans Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies Serve as a trainer for RA SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications. Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's degree in life sciences or a related field required; 3+ years of relevant regulatory clinical Science experience is required; OR Master's degree in life sciences or a related field required; 2+ years of relevant regulatory clinical Science experience is required 2+ years clinical programs experience in the biotechnology or pharmaceutical industry preferred Experience in the preparation of the submission of clinical modules in eCTD format is preferred Familiarity with organizing responses to Health Authority information requests is preferred Familiarity with regulatory submissions internationally is preferred. Knowledge, Skills, & Abilities Knowledge of Health Authority clinical guidance documents and requirements Knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines Strong Attention to detail Strong knowledge of clinical documentation and terminology 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. Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. This desk-based role involves close study of scientific and regulatory documents. This position will work closely with scientific colleagues throughout the day, often on a project-team basis. Lift and carry materials weighing up to