Regulatory Documentation Specialist II
ImmunityBio, Inc.
June 27, 2026
On-site
Summit, NJ
Corporate Functions
Position Summary
The Specialist II, Regulatory Documentation reports to the Director, Regulatory Documentation and will support the management and publishing of documents to ensure conformance with Health Authority requirements, including coordination of Electronic Common Tech Document (eCTD) modules.
Essential Functions
- Create and maintain electronic project folders for projects
- Generate electronic files for working documents
- Format documents per stipulated style guides for reports, assessments, regulatory submissions, letters, etc.
- Format and compile documents according to Regulatory Agency requirements
- Publish documents (internal bookmarks/hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents/datasets on the XML backbone
- Ensure working files, forms, sign-out sheets, and archives are organized and maintained per SOPs and Health Authority requirements
- Prepare document shells for inclusion of text and data
- Assist in training Regulatory Documentation Specialists; provide ongoing support after training
- Perform ad-hoc/cross-functional duties and/or projects as assigned
Education & Experience
- Bachelor’s degree in life sciences or technical discipline with 2+ years regulatory operations experience in biotechnology/pharma (required)
- OR High school diploma with 6+ years regulatory operations experience (required)
Knowledge, Skills, & Abilities
- Health Authority guidance/procedures for document management and electronic submissions
- Electronic Document Management Systems
- Veeva Vault (especially Veeva RIM)
- Meet firm deadlines; adapt to changing requirements
- Strong organization, written/oral communication, attention to detail
Benefits (eligible employees)
- Medical, Dental and Vision Plan Options; Health/Financial Wellness Programs; EAP; life/AD&D, short- and long-term disability; Flexible Spending Accounts; 401(k) match; 529; Paid Time Off (11 Holidays); Unlimited PTO for exempt; Non-exempt PTO/vacation/pay details as listed.
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.
The Specialist II, Regulatory Documentation reports to the Director, Regulatory Documentation and will support the management and publishing of documents to ensure conformance with Health Authority requirements, including coordination of Electronic Common Tech Document (eCTD) modules.
Essential Functions
- Create and maintain electronic project folders for projects
- Generate electronic files for working documents
- Format documents per stipulated style guides for reports, assessments, regulatory submissions, letters, etc.
- Format and compile documents according to Regulatory Agency requirements
- Publish documents (internal bookmarks/hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents/datasets on the XML backbone
- Ensure working files, forms, sign-out sheets, and archives are organized and maintained per SOPs and Health Authority requirements
- Prepare document shells for inclusion of text and data
- Assist in training Regulatory Documentation Specialists; provide ongoing support after training
- Perform ad-hoc/cross-functional duties and/or projects as assigned
Education & Experience
- Bachelor’s degree in life sciences or technical discipline with 2+ years regulatory operations experience in biotechnology/pharma (required)
- OR High school diploma with 6+ years regulatory operations experience (required)
Knowledge, Skills, & Abilities
- Health Authority guidance/procedures for document management and electronic submissions
- Electronic Document Management Systems
- Veeva Vault (especially Veeva RIM)
- Meet firm deadlines; adapt to changing requirements
- Strong organization, written/oral communication, attention to detail
Benefits (eligible employees)
- Medical, Dental and Vision Plan Options; Health/Financial Wellness Programs; EAP; life/AD&D, short- and long-term disability; Flexible Spending Accounts; 401(k) match; 529; Paid Time Off (11 Holidays); Unlimited PTO for exempt; Non-exempt PTO/vacation/pay details as listed.
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.