Manager, Regulatory Operations

Submission Management:

• Coordinates and publishes submissions to regulatory Health Authorities in the appropriate eCTD format using Veeva RIM.
• Monitors submission timelines and proactively identifies risks or delays.
• Maintains accurate, audit-ready records and metadata within Veeva RIM to support regulatory compliance.

System Optimization:

• Implements and optimizes Veeva RIM workflows to streamline submission processes and improve operational efficiency.
• Collaborates with QA, IT, and/or 3rd parties to ensure Veeva RIM system configurations meet evolving regulatory and business needs.
• Provides training and guidance to regulatory staff on Veeva RIM functionality and best practices.

Regulatory Compliance:

• Maintains current knowledge of existing and emerging regulations, standards, or guidance’s related to electronic submission and publishing requirements.
• Develops standard operational procedures, work instructions, and systems to ensure regulatory compliance.
• Establishes and maintains the regulatory archive in the eTMF Veeva Vault structure as necessary.