Overview In this role you drive Moderna's regulatory data strategy and governance as the Business Capability Owner for Veeva Vault RIM data. You will spearhead enterprise data standards, data quality, and global regulatory processes, collaborating across Regulatory Affairs, Operations, CMC, and Digital to enable scalable, compliant solutions. You'll lead initiatives like IDMP/xEVMPD and AI-enabled data management to improve regulatory intelligence and decision-making. This is a hands-on leadership role shaping Moderna's digital regulatory ecosystem and transformation.
Compensation / Benefits- competitive healthcare benefits
- fertility/adoption/surrogacy support
- mindfulness and mental health resources
- family planning benefits
- generous paid time off (vacation, volunteer days, sabbatical)
- discretionary year-end shutdown/renewal benefits
Responsibilities- Own and evolve regulatory master data capabilities and related processes (Applications, Registrations, Regulatory Submissions, Health Authority Interactions, SCP).
- Define strategy, governance, and multi-year roadmaps for Veeva Vault RIM data capabilities.
- Establish enterprise data standards, stewardship models, metadata, business rules, and data quality practices.
- Lead global regulatory data initiatives (IDMP, xEVMPD) ensuring alignment with HA requirements.
- Define and execute AI-enabled data management strategies (Vibe Coding, automation, analytics).
- Develop and maintain enterprise reporting and dashboards (Veeva Vault RIM, Tableau).
- Define strategies for enterprise integrations (AdPromo, Change Control, Data Lake).
- Establish Regulatory Data Migration methodologies and reusable assets.
- Partner with Digital to translate business requirements into tecnologia capabilities and improvements.
- Lead business readiness for Veeva Vault RIM releases (impact assessments, testing, adoption, training).
- Ensure regulatory data security, access governance, and inspection readiness.
- Act as enterprise SME for Regulatory Data Management across functions.
- Influence enterprise regulatory data strategy while balancing leadership with execution.
- May manage direct reports, contractors, and external service providers.
Key requirements- Bachelor's degree with 12+ years in Regulatory Affairs/Operations/Data Management/Computer Science or related fields
- Master's degree with 10+ years of relevant experience
- Extensive experience with Veeva Vault RIM including data objects, workflows, reporting, security, integrations, release management
- Experience as Business Capability Owner/Product Owner/Functional Lead for Veeva Vault RIM
- Strong understanding of global regulatory submissions, registrations, and Health Authority interactions
- Experience with global structured regulatory data standards (IDMP, xEVMPD)
- Proven governance program leadership, technology implementations, or data migration projects
- Experience collaborating with Digital to define business requirements and deliver capabilities
- Excellent communication and stakeholder management
- Organizational change management and leadership
- Cross-functional collaboration and influence
- Veeva Vault RIM data architecture, object model, reporting, metadata, security, release management
- Tableau or similar BI platforms for dashboards/analytics
- Regulatory data standards (IDMP, xEVMPD)
