Senior Veeva Vault RIM Specialist

Role: Senior Veeva Vault RIM Specialist

Role Description:

• Regulatory Information Management:
  • Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM.
  • Ensure that regulatory submissions comply with applicable local and international regulations and guidelines.
  • Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents.
• System Configuration and Maintenance:
  • Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows.
  • Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution.
• Data Management:
  • Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones.
  • Implement data governance practices to maintain compliance and quality of regulatory data.
• Cross-Functional Collaboration:
  • of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities.
• Process Improvement:
  • Identify opportunities for process enhancements and automation within the regulatory submission process.
  • Develop and implement standard operating procedures (SOPs) for the use of Veeva Vault RIM.
• Regulatory Compliance:
  • Stay updated on regulatory changes and ensure that the organization s processes and systems comply with current regulations and industry best practices.
  • Participate in audits and inspections as necessary, providing documentation and system access as required.