Regulatory Operations Consultant

Overview

Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM, with a primary focus on archiving legacy regulatory content and mitigating documentation into Veeva Vault. This role will play a key part in submission readiness, ensuring regulatory documentation is properly structured, archived, migrated, and maintained in accordance with current regulatory and system standards. The ideal candidate will have hands-on experience working in the current version of Veeva Vault RIM and a strong understanding of regulatory submission workflows, content planning, and document lifecycle management.

• Support day-to-day Veeva Vault RIM operations, with a focus on archiving and remediation of regulatory documentation.
• Execute and maintain submission content plans, ensuring accurate document structure, metadata, and lifecycle states.
• Perform archiving and mitigation of legacy regulatory content into Veeva Vault in alignment with internal standards and regulatory requirements.
• Support submission readiness activities, including document QC, completeness checks, and inspection preparedness.
• Conduct configuration testing within Veeva Vault RIM to validate workflows, metadata, and submission outputs.
• Support development and delivery of end-user training, including SOPs, job aids, and hands-on system guidance.
• Prepare, QC, and finalize regulatory documents using Adobe Acrobat (bookmarking, hyperlinking, formatting, and optimization).
• Utilize Doc Shifter to support document conversion and submission-ready outputs.
• Partner cross-functionally with Regulatory Affairs, Publishing, and IT stakeholders.
• Identify process gaps and recommend improvements related to regulatory content management and system use.

• Hands-on experience with the current version of Veeva Vault RIM and a strong understanding of regulatory submission workflows, content planning, and document lifecycle management.
• Experience supporting submission readiness activities and document QC.