Regulatory Documentation Specialist II
ImmunityBio, Inc.
August 15, 2026
On-site
Summit, NJ
Corporate Functions
Position Summary:
The Specialist II, Regulatory Documentation provides support in 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 according to stipulated style guides (reports, assessments, regulatory submissions, letters, etc.)
- Format and compile documents per Regulatory Agency requirements
- Publish documents (internal bookmarks and 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; answer questions and provide support after training
- Perform ad-hoc and cross-functional duties/projects as assigned
Education & Experience:
- Bachelor’s in life sciences/technical discipline with 2+ years of regulatory operations experience (biotech/pharma) required; or
- High school diploma with 6+ years regulatory operations experience (biotech/pharma) required
Knowledge, Skills & Abilities:
- Working knowledge of Health Authority procedures/guidance for document management and electronic submissions
- Working knowledge of Electronic Document Management Systems
- Working knowledge of Veeva Vault, especially Veeva RIM
- Meet firm deadlines and adapt to changing requirements
- Strong organization, written/oral communication, and attention to detail
On-site on Monday–Friday in Summit, NJ (standard business hours; flexibility with manager approval).
Benefits:
- Medical, Dental, Vision plan options; health and financial wellness programs; EAP; life/AD&D, short- and long-term disability; flexible spending accounts; 401(k) match; 529 program; PTO (11 holidays for non-exempt/Exempt unlimited PTO details); plus additional listed voluntary/perk offerings.
Application Instructions:
- Application window anticipated to close 60 days from posting or sooner if filled/closed.
The Specialist II, Regulatory Documentation provides support in 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 according to stipulated style guides (reports, assessments, regulatory submissions, letters, etc.)
- Format and compile documents per Regulatory Agency requirements
- Publish documents (internal bookmarks and 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; answer questions and provide support after training
- Perform ad-hoc and cross-functional duties/projects as assigned
Education & Experience:
- Bachelor’s in life sciences/technical discipline with 2+ years of regulatory operations experience (biotech/pharma) required; or
- High school diploma with 6+ years regulatory operations experience (biotech/pharma) required
Knowledge, Skills & Abilities:
- Working knowledge of Health Authority procedures/guidance for document management and electronic submissions
- Working knowledge of Electronic Document Management Systems
- Working knowledge of Veeva Vault, especially Veeva RIM
- Meet firm deadlines and adapt to changing requirements
- Strong organization, written/oral communication, and attention to detail
On-site on Monday–Friday in Summit, NJ (standard business hours; flexibility with manager approval).
Benefits:
- Medical, Dental, Vision plan options; health and financial wellness programs; EAP; life/AD&D, short- and long-term disability; flexible spending accounts; 401(k) match; 529 program; PTO (11 holidays for non-exempt/Exempt unlimited PTO details); plus additional listed voluntary/perk offerings.
Application Instructions:
- Application window anticipated to close 60 days from posting or sooner if filled/closed.