Spark Life Solutions IncRemote
Regulatory Business Analyst
United States of America
Full Time
6 days ago
$50 USD
H1B Sponsor Likely
Key skills
AIGenAISparkVaultSDLC
About this role
Spark Life Solutions Inc is seeking a Regulatory Business Analyst to support their regulatory business processes. The role involves managing Veeva Vault RIM capabilities, gathering business requirements, and contributing to regulatory technology modernization initiatives.
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
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
- Candidates with experience in IDMP, eCTD, AI/automation, and Veeva integrations are highly preferred