Associate Director, Regulatory Data Management & Intelligence

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 worlds most innovative biotechnology companies. As a strategic leader within Regulatory Information Management (RIM) you will shape Modernas 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.

Heres What Youll Do

• Report to the Director Regulatory Information Management (RIM) as a key leader responsible for advancing Modernas 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 Modernas Regulatory Information Management organization.

• Ensure regulatory information is accurate standardized secure and positioned to support evolving global regulatory requirements while enabling Modernas 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 Modernas business ownership for IDMP xEVMPD and future global structured regulatory data initiatives ensuring alignment with evolving Health Authority requirements.

• Define and execute Modernas 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 Modernas 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 Modernas 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 youll need to succeed in the role

We obsess over learning. We dont 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.

Heres What Youll Need (Basic Qualifications)

• Bachelors degree with 12 years of experience in Regulatory Affairs Regulatory Operations Regulatory Information Management Data Management Computer Science or related disciplines.

• Masters 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.

Heres What Youll 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 Lake architectures.

• Experience leveraging artificial intelligence automation advanced analytics or Vibe Coding to improve regulatory business processes.

• Excellent communication stakeholder management organizational change management and leadership skills.

• Ability to influence cross-functional teams while balancing strategic leadership with hands-on execution.

• A desire to make an impact as part of a high-growth transformational company that is Bold Relentless Curious and Collaborative.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our benefits and well-being resources are designed to support youat work at home and everywhere in between.

• Competitive healthcare plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness mindfulness and mental health support
• Family building benefits including fertility adoption and surrogacy support
• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savingsandinvestments to help you plan for the future
• Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our peopleare the driving force behind our scientific progress and our we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .

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