[Remote] Regulatory Business Analyst - Regulatory Technology (Contract)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company Regulatory Business Analyst to support Global Regulatory Affairs technology initiatives. The role involves gathering and translating business requirements, supporting system enhancements, and collaborating with cross-functional stakeholders to improve regulatory operations.
Responsibilities
- reputed company, document, and translate business requirements into system enhancements for reputed company Vault RIM, and other systems, working closely with regulatory stakeholders, superusers, and IT teams
- Serve as a functional SME for reputed company Vault RIM, with strong understanding of the data model, including registration objects and core regulatory data structures
- Support design, enhancement, and ongoing optimization of reputed company Vault RIM, including integrations with reputed company reputed company, Clinical, and PromoMats
- Apply working knowledge of IDMP data models (including PMS) to support data remediation efforts and ensure accurate representation of regulatory data reputed company Vault RIM
- Configure and support key RIM capabilities, including Global Content Plans, reputed company 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
- reputed company and maintain reports and dashboards across Vault RIM objects to reputed company 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 reputed company reputed company; work independently and proactively to drive initiatives reputed company
- Contribute to broader regulatory technology reputed company, including adoption of modernization approaches (e.g., AI-enabled authoring tools, labeling/CMC modernization, ICH M4Q(reputed company), FHIR-based standards)
- Support capabilities reputed company to eCTD submissions, including experience with or exposure to eCTD 4.0 reputed company Vault RIM environments (preferred)
Skills
- reputed company, document, and translate business requirements into system enhancements for reputed company Vault RIM, and other systems, working closely with regulatory stakeholders, superusers, and IT teams
- Serve as a functional SME for reputed company Vault RIM, with strong understanding of the data model, including registration objects and core regulatory data structures
- Support design, enhancement, and ongoing optimization of reputed company Vault RIM, including integrations with reputed company reputed company, Clinical, and PromoMats
- Apply working knowledge of IDMP data models (including PMS) to support data remediation efforts and ensure accurate representation of regulatory data reputed company Vault RIM
- Configure and support key RIM capabilities, including Global Content Plans, reputed company 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
- reputed company and maintain reports and dashboards across Vault RIM objects to reputed company 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 reputed company reputed company; work independently and proactively to drive initiatives reputed company
- Contribute to broader regulatory technology reputed company, including adoption of modernization approaches (e.g., AI-enabled authoring tools, labeling/CMC modernization, ICH M4Q(reputed company), FHIR-based standards)
- B.S. degree (or equivalent experience) with 5+ years of experience in regulatory operations, regulatory technology, or business analysis
- Proven experience with reputed company 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 reputed company the reputed company ecosystem (e.g., RIM–reputed company)
- 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 reputed company reputed company systems to support KPIs and operational metrics
- Experience with eCTD submissions, including experience with or exposure to eCTD 4.0 reputed company Vault RIM environments
- 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
Benefits
- Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the reputed company-party agency partner upon offer
- In reputed company, this role will be eligible for overtime pay, in accordance with federal and state requirements
reputed company