Regulatory Operations Consultant
Katalyst HealthCares & Life Sciences, Boston, MA, United States
Job description:
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.
Responsibilities:
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 DocShifter 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.
Responsibilities:
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 DocShifter 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.