Associate Director, Regulatory Data Management & Intelligence

About the role

This role is an exciting opportunity to be an integral part of the talent engine fueling a high-growth organization that is radically changing the biotech industry. Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management & Intelligence is responsible for defining and advancing Moderna’s regulatory data strategy, governance framework, and digital data ecosystem.

Responsibilities

• Serve as the Business Capability Owner for assigned Veeva Vault RIM Data capabilities, defining the strategy, governance framework, and multi-year roadmap supporting Moderna’s Regulatory Information Management organization.
• Own and continuously improve regulatory master data capabilities including Applications, Registrations, Regulatory Objectives, Regulatory Submissions, Health Authority Interactions, Structured Content Planning (SCP), and related regulatory business processes.
• Establish and maintain enterprise regulatory data standards, governance processes, stewardship models, metadata, business rules, and data quality practices supporting global regulatory operations.
• Lead Moderna’s business ownership for IDMP, xEVMPD, and future global structured regulatory data initiatives, ensuring alignment with evolving Health Authority requirements.
• Define and execute Moderna’s strategy for AI-enabled regulatory data management, leveraging artificial intelligence, Vibe Coding, automation, and advanced analytics to improve regulatory intelligence, operational efficiency, and business decision-making.
• Develop and maintain enterprise reporting, dashboards, and analytics utilizing Veeva Vault RIM, Tableau, and future business intelligence platforms.
• Define the business strategy supporting enterprise integrations, including AdPromo, Change Control, Enterprise Data, and Data Lake capabilities.
• Establish Moderna’s Regulatory Data Migration capability, developing repeatable methodologies, governance models, business rules, and reusable migration assets supporting future regulatory technology implementations.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
• Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
• Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
• Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications