Associate Director, Regulatory Data Management & Intelligence

If you’re interested in this role, please apply in English and include an English version of your Resume/CV. The Role Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international business services hub in Warsaw, supporting our growing global operations. We welcome professionals ready to help advance our mission and shape the future of mRNA medicines. This is an exceptional opportunity to define the future of regulatory data management within one of the world's most innovative biotechnology companies. As a strategic leader within Regulatory Information Management (RIM), you will shape Moderna's regulatory data strategy, governance, and digital ecosystem while leveraging AI, automation, advanced analytics, and emerging technologies to transform global regulatory operations. Working across a broad network of business and digital partners, you will help build scalable, compliant, and intelligent regulatory capabilities that accelerate how we bring innovative medicines to patients. Here's What You’ll Do Report to the Director, Regulatory Information Management (RIM) as a key leader responsible for advancing Moderna's regulatory data strategy, governance framework, and digital regulatory ecosystem. Serve as the Business Capability Owner for assigned Veeva Vault RIM Data capabilities, defining the long-term strategy, governance framework, and multi-year roadmap supporting Moderna's Regulatory Information Management organization. Ensure regulatory information is accurate, standardized, secure, and positioned to support evolving global regulatory requirements while enabling Moderna's broader digital transformation strategy. Own and continuously enhance regulatory master data capabilities, including Applications, Registrations, Regulatory Objectives, Regulatory Submissions, Health Authority Interactions, Structured Content Planning (SCP), and associated regulatory business processes. Establish and maintain enterprise-wide regulatory data standards, governance processes, stewardship models, metadata, business rules, and data quality practices that support 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 AI-enabled regulatory data management strategy by 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 to generate meaningful business insights. Define the business strategy supporting enterprise integrations, including AdPromo, Change Control, Enterprise Data, and Data Lake capabilities. Establish Moderna's Regulatory Data Migration capability by developing repeatable methodologies, governance models, business rules, and reusable migration assets that support future regulatory technology implementations. Partner closely with Digital teams 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, compliance requirements, data integrity, and inspection readiness are consistently maintained. Serve as the enterprise subject matter expert for Regulatory Data Management, collaborating across Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, Digital, and external technology partners to deliver scalable, compliant, and innovative business solutions. Influence Moderna's enterprise regulatory data strategy while balancing strategic leadership with hands-on execution and a continuous improvement mindset. Build trusted partnerships across cross-functional stakeholders to strengthen regulatory business processes, regulatory data quality, and enterprise technology capabilities. Support the management of direct reports, contractors, consultants, and external service providers as business needs evolve. The key Moderna Mindsets you'll need to succeed in the role "We obsess over learning. We don’t have to be the smartest we have to learn the fastest." "We digitize everywhere possible using the power of code to maximize our impact on patients." Here’s What You’ll Need (Basic 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. Proficiency in English (verbal and/or written) required due to global collaboration needs. Here’s What You’ll Bring to the Table (Preferred 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