Veeva RIM Specialist

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.

• 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, life cycles, 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.

• 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).

• 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.