Hiring: Regulatory Documentation Specialist II Company: ImmunityBio, Inc. Location: Summit, NJ Job Posted Time: 2026-09-10 11:58:35 Employment Type: On-site Target Skills & Keywords : AI, Vault About the job Experience: •Bachelor’s Degree in life sciences or technical discipline with 2+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or High school diploma with 6+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required. Required Skills: •Create and maintain electronic project folders for projects •Generate electronic files for working documents •Format documents prepared or received according to stipulated style guides for reports, assessments, regulatory submissions, letters, etc. •Format and compile documents according to requirements specified by Regulatory Agencies •Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone •Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements •Prepare document shells for inclusion of text and data •Assist in training Regulatory Documentation Specialists ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed Qualifications: •Solid functional working knowledge of Health Authority procedures and guidance regarding document management and electronic submissions •Solid functional working knowledge of Electronic Document Management Systems •Solid functional working knowledge of Veeva Vault especially Veeva RIM •Demonstrated capacity 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 •This position works on-site (Monday through Friday) in Summit, NJ. •Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval. •This 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 colleagues throughout the day, often on a project-team basis. Compensation: •Flexible work environment (work from home / hybrid options) •This position is eligible for a discretionary bonus and equity award Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!