Associate Director, Regulatory Data Management & Intelligence
$142,500–$256,500 year
On-siteCambridge, Massachusetts, United States
Job Summary
Define and advance Moderna's regulatory data strategy, governance framework, and digital ecosystem as the Business Capability Owner for Veeva Vault RIM Data. Own regulatory master data capabilities including Applications, Registrations, and Submissions while establishing enterprise standards, stewardship models, and data quality practices. Lead business ownership for IDMP, xEVMPD, and future structured regulatory data initiatives, ensuring alignment with evolving Health Authority requirements. Execute AI-enabled regulatory data management strategies leveraging automation and advanced analytics to improve operational efficiency. Develop enterprise reporting dashboards, manage business readiness for Veeva Vault releases, and establish regulatory data migration methodologies. Partner with Regulatory Affairs, CMC, Quality, and Digital to deliver scalable, compliant solutions while maintaining data security and inspection readiness. May manage direct reports and external service providers.
Required Qualifications
- Bachelor's degree
- 12+ years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, Data Management, Computer Science, or related disciplines
- Master's degree
- 10+ years of relevant experience
- Extensive experience with Veeva Vault RIM
- Business ownership of regulatory data objects, workflows, reporting, object security, integrations, and release management
- Demonstrated experience serving as a Business Capability Owner, Product Owner, Functional Lead, or equivalent leadership role supporting Veeva Vault RIM capabilities
- Strong understanding of global regulatory submissions, registrations, regulatory master data, applications, and Health Authority interactions
- Experience supporting global structured regulatory data standards including IDMP, xEVMPD, or similar regulatory initiatives
- Demonstrated experience leading enterprise governance programs, technology implementations, business transformation initiatives, or regulatory data migration projects
- Experience partnering with Digital organizations to develop business requirements and deliver enterprise technology capabilities
- Ability to access export-controlled information in accordance with U.S. law
- Qualify as U.S. persons (citizens, permanent residents, asylees, or refugees)
Desired Qualifications
- Deep understanding of Regulatory Information Management and enterprise regulatory data governance
- Advanced knowledge of Veeva Vault RIM data architecture, object model, reporting capabilities, metadata, security, and release management
- Experience with Veeva Vault RIM Applications, Registrations, Submissions, Products, Organizations, and Health Authority data objects
- Experience utilizing Tableau, Veeva reporting, or comparable business intelligence platforms to develop enterprise dashboards and analytics
- Experience leading enterprise data migration initiatives and regulatory technology implementations
- Knowledge of enterprise integrations, APIs, middleware, and Data Lake architectures
- Experience leveraging artificial intelligence, automation, advanced analytics, or Vibe Coding to improve regulatory business processes
- Excellent communication, stakeholder management, organizational change management, and leadership skills
- Ability to influence cross-functional teams while balancing strategic leadership with hands-on execution
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
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