Regulatory Documentation Specialist III
ImmunityBio, Inc.
June 30, 2026
On-site
Summit, NJ
Corporate Functions
Position Summary
Specialist III, Regulatory Documentation will provide expertise in the management and publishing of documents to ensure conformance with Health Authority requirements, assisting with document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.
Essential Functions
- Create and maintain electronic project folders
- Advise internal departments on preparation and submission of regulatory documentation
- Generate electronic files for working documents
- Format documents per style guides for reports, assessments, regulatory submissions, letters, etc.
- Format and compile documents per Regulatory Agency requirements
- QC documents (formatting, bookmarking, hyperlinking, document properties)
- Create new submissions in submission software per SOPs; complete checklists
- Publish documents (internal bookmarks/hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks
- Submit documents to Health Authorities
- Maintain organized working files, forms, signout sheets, and archives per SOPs and Health Authority requirements
- Prepare templates and document shells
- Assist in training Regulatory Documentation Specialists and provide post-training support
- Collaborate on regulatory documentation software upgrades/new programs/removals
- Perform ad-hoc and cross-functional duties/projects as assigned
Education & Experience (Required)
- Bachelor’s in life sciences or technical discipline with 5+ years regulatory operations experience in biotech/pharma; or
- High school diploma with 9+ years regulatory operations experience in biotech/pharma
Knowledge/Skills (Required/Preferred)
- Expert Health Authority guidance for document management and electronic submissions
- Expert Electronic Document Management Systems
- Strong Veeva Vault knowledge (especially Veeva RIM)
- Ability to meet deadlines and adapt to changing priorities
- Strong organizational skills, written/oral communication, and attention to detail
Benefits
- Medical, Dental and Vision Plan Options; Health and Financial Wellness Programs; EAP; Life/AD&D; Short-Term and Long-Term Disability; Healthcare and Dependent Care FSAs; 401(k) match; 529 Education Savings; Legal services/identity theft/pet insurance/employee discounts; Paid Time Off (11 holidays); Unlimited PTO for Exempt; Non-Exempt PTO details provided
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
Specialist III, Regulatory Documentation will provide expertise in the management and publishing of documents to ensure conformance with Health Authority requirements, assisting with document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.
Essential Functions
- Create and maintain electronic project folders
- Advise internal departments on preparation and submission of regulatory documentation
- Generate electronic files for working documents
- Format documents per style guides for reports, assessments, regulatory submissions, letters, etc.
- Format and compile documents per Regulatory Agency requirements
- QC documents (formatting, bookmarking, hyperlinking, document properties)
- Create new submissions in submission software per SOPs; complete checklists
- Publish documents (internal bookmarks/hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks
- Submit documents to Health Authorities
- Maintain organized working files, forms, signout sheets, and archives per SOPs and Health Authority requirements
- Prepare templates and document shells
- Assist in training Regulatory Documentation Specialists and provide post-training support
- Collaborate on regulatory documentation software upgrades/new programs/removals
- Perform ad-hoc and cross-functional duties/projects as assigned
Education & Experience (Required)
- Bachelor’s in life sciences or technical discipline with 5+ years regulatory operations experience in biotech/pharma; or
- High school diploma with 9+ years regulatory operations experience in biotech/pharma
Knowledge/Skills (Required/Preferred)
- Expert Health Authority guidance for document management and electronic submissions
- Expert Electronic Document Management Systems
- Strong Veeva Vault knowledge (especially Veeva RIM)
- Ability to meet deadlines and adapt to changing priorities
- Strong organizational skills, written/oral communication, and attention to detail
Benefits
- Medical, Dental and Vision Plan Options; Health and Financial Wellness Programs; EAP; Life/AD&D; Short-Term and Long-Term Disability; Healthcare and Dependent Care FSAs; 401(k) match; 529 Education Savings; Legal services/identity theft/pet insurance/employee discounts; Paid Time Off (11 holidays); Unlimited PTO for Exempt; Non-Exempt PTO details provided
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).