Regulatory Data Strategy Lead – RIM & Intelligence

RXinsider LTD.

Cambridge (MA)

On-site

USD 143,000 - 257,000

Full time

14 days+

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Benefits offered by this job

Competitive healthcare

Well‑being resources

Family planning benefits

Paid time off

Job summary

Moderna is seeking an Associate Director, Regulatory Data Management & Intelligence to define and advance the regulatory data strategy, governance, and digital data ecosystem. Reporting to the Director, RIM, you will serve as the Business Capability Owner for Veeva Vault RIM Data capabilities and partner with Regulatory Affairs, Compliance, and IT to deliver scalable, compliant solutions.

This role balances strategic leadership with hands‑on execution, driving AI-enabled data management, data

Qualifications

Bachelor’s degree with 12+ years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, Data Management, Computer Science, or related disciplines.
Master’s degree with 10+ years of relevant experience.
Extensive experience with Veeva Vault RIM is required, including 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.

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.
Serve as the enterprise subject matter expert for Regulatory Data Management, partnering across Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, and Digital to deliver scalable, compliant, and innovative business solutions.
Influence enterprise regulatory data strategy while balancing strategic leadership with hands‑on execution and continuous improvement.
May manage direct reports, contractors, consultants, and external service providers.