Associate Director, Health Authorities

Benefits

Additional Information

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 Associate Director, Health Authorities will aid the advance of global clinical regulatory compliance for investigational and marketed products and manage the preparation, review, and finalization of submission packages and responses to Health Authorities. This position will contribute to the preparation of INDs, CTAs, BLAs, MAAs, and any other application for health authorities in line with local requirements. Essential Functions Lead Health Authorities direct reports by delegating projects, establishing and meeting timelines, and ensuring high quality work products Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance. Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document Provide input to the design and reporting of clinical studies sponsored by IBRX Manage the preparation of the relevant clinical sections of written summaries for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and any other applications. Create and maintain project plans for health authorities operations Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, and subject matter experts / key opinion leaders to gather data, craft high‑quality RFI responses, and foster constructive agency relationships Prepare and assign responses to Health Authority comments and questions pertaining to clinical issues. Maintain timelines on responses and assemble the final, completed submission package. Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications Ensure continuous monitoring of, and incorporation of, the most recent regional and local health‑authority guidances; interpret amendments and apply updated requirements to all regulatory dossiers to mitigate agency queries and preserve submission integrity Oversee version‑control governance by supervising a centralized document repository, defining naming‑convention standards, authorizing change‑tracking procedures, and approving final module versions prior to electronic upload to ensure audit‑ready documentation Develop and maintain product‑development road maps based on projected approval dates 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 technical discipline with 10+ years of relevant progressive experience required; or Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required. Experience managing staff required Experience in the management and preparation of the submission of clinical modules in eCTD format required. Experience in medical writing Experience with organizing responses to Health Authority information requests required. Experience with regulatory submissions outside of the US preferred Knowledge, Skills, & Abilities Expert knowledge of Health Authority guidance documents and requirements Strong leadership skills with the ability to direct and develop professional staff Exp