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Associate Director, Regulatory Data Management & Intelligence

Moderna

Senior
Sign in to applyVerified 2h ago
Level
Senior
Posted
8h ago

Skills

Tableau

About this role

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

Associate Director, Regulatory Data Management & Intelligence at Moderna | Yoinka