Tech Stack

Description

You will lead regulatory archiving and information management, ensuring compliant classification and retrieval of submissions and health authority correspondence. Using Veeva Vault RIM, you'll define metadata standards, support inspections, and train stakeholders, evolving into a strategic role as automation advances.

Requirements

• Bachelor's degree required; advanced degree preferred.
• 7-10 years experience in Regulatory Affairs, Regulatory Operations, or Regulatory Information Management in pharma/biotech.
• Hands-on experience with Veeva Vault RIM including document management and records lifecycle.
• Strong knowledge of global regulatory submissions and health authority correspondence processes.
• Excellent attention to detail, organizational skills, and ability to work independently.

Responsibilities

• Serve as SME for regulatory submissions and health authority correspondence, interpreting and classifying correspondence types.
• Execute and oversee archiving of submissions and correspondence, ensuring accuracy, completeness, and retrievability.
• Define, maintain, and enforce archival/metadata standards including controlled vocabularies within Veeva Vault RIM.
• Monitor metadata quality, identify/data quality issues, and drive remediation.
• Support inspection readiness and respond to document requests for business development due diligence.