Regulatory Business Analyst - Regulatory Technology (Contract)

Vertex Pharmaceuticals is seeking an experienced Regulatory Business Analyst to support Global Regulatory Affairs technology initiatives. The role involves gathering business requirements, enhancing systems like Veeva Vault RIM, and collaborating with cross-functional teams to optimize regulatory operations.

Responsibilities:

• 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:

• 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)
• 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
• Experience with eCTD 4.0 within Vault RIM environments
• Exposure to AI/GenAI tools, automation, or digital transformation initiatives in regulatory or content processes