Veeva RIM Specialist
ImmunityBio, Inc.
August 07, 2026
On-site
Summit, NJ
IT
Position Summary
The Veeva RIM Specialist provides expertise in the management and publishing of regulatory documents to ensure conformance with Health Authority requirements. Hands-on execution supporting US and ex-US regulatory activities and maintaining an inspection-ready system. Assists with submission and document management activities using Veeva RIM.
Essential Functions
- Create and maintain electronic project folders.
- Upload, track, and maintain life cycle of regulatory submissions (INDs, BLAs, CTAs) for US and ex-US regions in Veeva RIM.
- Maintain Veeva RIM by uploading submissions, Health Authority correspondence, etc.
- Track regulatory meetings, questions, information requests, and responses; ensure proper linking in Veeva RIM.
- Upload/manage Word and source documents in Veeva Vault for collaboration, version control, and updates.
- Capture and file regulatory documents received via email, secure links, or external portals in addition to gateway submissions.
- Assist with internal audits, Health Authority inspections, and regulatory inquiries related to RIM documentation.
- Organize and maintain working files, forms, sign-out sheets, and archives per SOPs and Health Authority requirements.
- Configure Vault objects, lifecycles, workflows, document types, and metadata.
- Provide technical/functional support for Veeva RIM user access.
- Assist with system validation, upgrades, and testing (GxP and regulatory standards).
- Partner with Regulatory Affairs, IT, and clinical teams to translate business requirements into technical solutions.
- Train Regulatory Documentation Specialists; provide post-training support.
- Serve as operational contact for Regulatory Affairs regarding Veeva RIM; provide day-to-day user support.
- Support upgrades/new software/removal of unused programs; perform ad-hoc cross-functional duties.
Education & Experience
- Bachelor’s in life sciences/technical discipline with 5+ years regulatory operations experience in biotech/pharma OR High School diploma with 9+ years.
- Hands-on experience with Veeva RIM and Veeva Vault.
- Global regulatory submissions and Health Authority correspondence familiarity (strongly preferred).
Knowledge, Skills & Abilities
- Expert knowledge of Health Authority procedures for document management/electronic submissions.
- Expert knowledge of Electronic Document Management Systems.
- Strong knowledge of Veeva Vault, especially Veeva RIM.
- Ability to meet deadlines and adapt to changing priorities.
- Strong organizational skills, written/oral communication, and attention to detail.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Veeva RIM Specialist provides expertise in the management and publishing of regulatory documents to ensure conformance with Health Authority requirements. Hands-on execution supporting US and ex-US regulatory activities and maintaining an inspection-ready system. Assists with submission and document management activities using Veeva RIM.
Essential Functions
- Create and maintain electronic project folders.
- Upload, track, and maintain life cycle of regulatory submissions (INDs, BLAs, CTAs) for US and ex-US regions in Veeva RIM.
- Maintain Veeva RIM by uploading submissions, Health Authority correspondence, etc.
- Track regulatory meetings, questions, information requests, and responses; ensure proper linking in Veeva RIM.
- Upload/manage Word and source documents in Veeva Vault for collaboration, version control, and updates.
- Capture and file regulatory documents received via email, secure links, or external portals in addition to gateway submissions.
- Assist with internal audits, Health Authority inspections, and regulatory inquiries related to RIM documentation.
- Organize and maintain working files, forms, sign-out sheets, and archives per SOPs and Health Authority requirements.
- Configure Vault objects, lifecycles, workflows, document types, and metadata.
- Provide technical/functional support for Veeva RIM user access.
- Assist with system validation, upgrades, and testing (GxP and regulatory standards).
- Partner with Regulatory Affairs, IT, and clinical teams to translate business requirements into technical solutions.
- Train Regulatory Documentation Specialists; provide post-training support.
- Serve as operational contact for Regulatory Affairs regarding Veeva RIM; provide day-to-day user support.
- Support upgrades/new software/removal of unused programs; perform ad-hoc cross-functional duties.
Education & Experience
- Bachelor’s in life sciences/technical discipline with 5+ years regulatory operations experience in biotech/pharma OR High School diploma with 9+ years.
- Hands-on experience with Veeva RIM and Veeva Vault.
- Global regulatory submissions and Health Authority correspondence familiarity (strongly preferred).
Knowledge, Skills & Abilities
- Expert knowledge of Health Authority procedures for document management/electronic submissions.
- Expert knowledge of Electronic Document Management Systems.
- Strong knowledge of Veeva Vault, especially Veeva RIM.
- Ability to meet deadlines and adapt to changing priorities.
- Strong organizational skills, written/oral communication, and attention to detail.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).