Regulatory Documentation Specialist III

About this role

Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

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 Documentation will report to the Director, Regulatory Documentation and will provide expertise and guidance in the management and publishing of documents ensuring their conformance with Health Authority requirements. This position will assist staff in the document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.

Essential Functions • Create and maintain electronic project folders for projects

• Serve as an advisor to internal departments in the preparation and submission of regulatory documentation

• 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

• QC documents (formatting, bookmarking, hyperlinking, document properties) that were prepared by others

• Create new submissions in submission software following all SOPs and ensuring all checklists are completed

• Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone

• Submit documents to Health Authorities.

• Ensure that all working files, forms, signout sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements

• Prepare templates and 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

• Collaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer needed

• 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 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or

• High school diploma with 9+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required

Knowledge, Skills, & Abilities • Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission

• Expert knowledge of Electronic Document Management Systems

• Strong knowledge in Veeva Vault especially Veeva RIM

• 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 (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

This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$50.48 (entry-level qualifications) to $55.53 (highly experienced) per hour

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.   Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers.

Similar jobs

• Regulatory Documentation Specialist II — ImmunityBio · Summit, NJ
• Regulatory Correspondence Specialist III — Newrez · Coppell, TX | Fort Washington, PA
• Regulatory Specialist — Globus Medical · Audubon, PA
• Regulatory Specialist — Lennar · Phoenix AZ - Virtual | Tallahassee FL - Virtual
• Regulatory Reporting Specialist — Point72 · Stamford, CT
• Document Controls Specialist III — HNTB · Cincinnati, OH (Brent Spence Bridge Project) | Blue Ash, OH (Cincinnati)
• Regulatory Affairs Specialist II — Abbott · United States > Lake Forest : CP01
• Regulatory Affairs Specialist II — Seattle Children's · Remote