Veeva Vault RIM - Regulatory Business Analyst

Stark Pharma Solutions Inc is seeking a Regulatory Business Analyst with expertise in Veeva Vault RIM to support regulatory operations and digital transformation initiatives. The role involves managing data integrity, supporting regulatory submission processes, and collaborating with cross-functional teams to optimize business processes.

Responsibilities:

• Support configuration, maintenance, and business processes within Veeva Vault RIM
• Perform regulatory data remediation and ensure data quality and integrity
• Support IDMP, eCTD, and regulatory submission processes
• Manage integrations between Veeva Vault Quality and Veeva Vault RIM
• Develop and monitor RIM reports, dashboards, and KPIs
• Coordinate UAT, review test scripts, and support system validation activities
• Create and maintain SOPs, training materials, and user documentation
• Collaborate with cross-functional teams on AI/GenAI, automation, and digital transformation initiatives
• Support continuous process improvements within regulatory systems

Requirements:

• Bachelor's degree in Life Sciences, Information Systems, or a related field
• 5+ years of experience as a Business Analyst supporting Regulatory Affairs systems
• Strong hands-on experience with Veeva Vault RIM (configuration, data model, and business process support)
• Experience with data remediation, IDMP, eCTD, and SDLC
• Knowledge of Veeva Vault Quality RIM integrations
• Experience supporting validation activities, including UAT and test script reviews
• Strong documentation skills with experience creating SOPs and training materials
• Exposure to AI/GenAI, automation, or digital transformation initiatives
• Familiarity with eCTD publishing solutions; eCTD 4.0 experience is a plus