Regulatory Business Analyst

• Looking for someone with technical experience with Veeva RIM.
• This person will be remediating data.
• Great to have - IDMP, eCTD, Veeva capabilities.
• SDLC.
• Experience with AI & the automation process space.
• Experience with integration between Veeva quality to Veeva RIM.
• Understands Veeva RIM reporting & KPIs.
• This person will be spending 65-70% of their time in Veeva RIM.
• Elicit, document, and translate business requirements into system enhancements for Veeva Vault RIM, and other systems, working closely with regulatory stakeholders, superusers, and IT teams.
• Serve as a functional SME for Veeva Vault RIM, with strong understanding of the data model, including registration objects and core regulatory data structures.
• Support design, enhancement, and ongoing optimization of Veeva Vault RIM, including integrations with Veeva Quality, Clinical, and PromoMats.
• Apply working knowledge of IDMP data models (including PMS) to support data remediation efforts and ensure accurate representation of regulatory data within Vault RIM.
• Configure and support key RIM capabilities, including Global Content Plans, Active Dossier setup, and dossier management across Modules 2 5.
• Partner with technical teams to support system design, validation, data migration, data cleansing, and UAT activities, including test script review.
• Develop and maintain reports and dashboards across Vault RIM objects to enable KPI tracking, data monitoring, and informed business decision-making.
• Collaborate cross-functionally to prioritize enhancements, drive process optimization, and ensure alignment between business needs and system capabilities.
• Support user education and change management, including development of training materials, business guidelines, and reference documentation.
• Communicate effectively with stakeholders at all levels; work independently and proactively to drive initiatives forward.
• Contribute to broader regulatory technology strategy, including adoption of modernization approaches (e.g., AI-enabled authoring tools, labeling/CMC modernization, ICH M4Q(R2), FHIR-based standards).
• Support capabilities related to eCTD submissions, including experience with or exposure to eCTD 4.0 within Vault RIM environments (preferred).

Requirements:

• B.S. degree (or equivalent experience) with 5+ years of experience in regulatory operations, regulatory technology, or business analysis.
• Proven experience with Veeva Vault RIM including configuration, data model understanding, and business process support.
• Experience with regulatory data standards (e.g., IDMP/PMS) and their application in system implementations or data remediation efforts.
• Experience with system integrations within the Veeva ecosystem (e.g., RIM Quality).
• Hands-on experience with requirements gathering, documentation, and translation into system enhancements.
• Experience supporting validation processes, including UAT coordination, test script review.
• Experience creating training materials, SOPs, and user documentation, and supporting adoption of new capabilities post-go-live.
• Experience with reporting and analytics within enterprise systems to support KPIs and operational metrics.
• Familiarity with eCTD publishing solutions; exposure to eCTD 4.0 is a plus.
• Exposure to AI/GenAI tools, automation, or digital transformation initiatives in regulatory or content processes is a plus.