Regulatory Business Analyst

Job Title: Regulatory Business Analyst Remote Key Requirements: • 5+ years of experience in Regulatory Operations, Regulatory Technology, or Business Analysis. • Strong hands-on experience with Veeva Vault RIM (configuration, data model, and business processes). • Experience with regulatory data remediation and management within Veeva RIM. • Knowledge of IDMP/PMS and regulatory data standards. • Experience with Veeva system integrations (e.g., Veeva RIM and Veeva Quality). • Familiarity with SDLC, system validation, UAT, and test script review. • Experience gathering business requirements and translating them into system enhancements. • Strong reporting and KPI/dashboard development experience within Veeva RIM. • Exposure to eCTD submissions (eCTD 4.0 preferred). • Experience with AI/GenAI, automation, or digital transformation initiatives is a plus. Responsibilities: • Act as the functional SME for Veeva Vault RIM and support regulatory business processes. • Gather and document business requirements and collaborate with stakeholders and IT teams. • Support data remediation, system enhancements, and process optimization activities. • Manage and optimize Veeva RIM capabilities, including Global Content Plans, Active Dossiers, and dossier management. • Support integrations between Veeva RIM and other Veeva applications (Quality, Clinical, PromoMats). • Assist with data migration, validation activities, UAT, and system testing. • Develop reports and dashboards for KPI tracking and regulatory data monitoring. • Create training materials, SOPs, and support user adoption of new capabilities. • Contribute to regulatory technology modernization initiatives involving AI, automation, and regulatory standards. Manager Notes: • Majority of work (65–70%) will be within Veeva Vault RIM. • Candidates with experience in IDMP, eCTD, AI/automation, and Veeva integrations are highly preferred.