Associate Director, Regulatory Data Management & Intelligence
Cambridge, MA - USA
Job Summary
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 Modernas regulatory data strategy governance framework and digital data ecosystem. This role serves as the Business Capability Owner for assigned Veeva Vault RIM Data capabilities ensuring regulatory information is accurate standardized secure and positioned to support evolving global regulatory requirements and Modernas digital transformation strategy.
The Associate Director will establish enterprise data governance define business capabilities and partner closely with Regulatory Affairs Regulatory Operations CMC Labeling Quality Enterprise Data Digital and external technology partners to continuously improve regulatory business processes regulatory data quality and enterprise technology capabilities. This role balances strategic leadership with hands-on execution serving as both a business capability owner and a trusted subject matter expert supporting Modernas global regulatory operations.
- Serve as the Business Capability Owner for assigned Veeva Vault RIM Data capabilities defining the strategy governance framework and multi-year roadmap supporting Modernas 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 Modernas business ownership for IDMP xEVMPD and future global structured regulatory data initiatives ensuring alignment with evolving Health Authority requirements.
- Define and execute Modernas 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 Modernas 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.
- 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.
- 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 planning benefits including fertility adoption and surrogacy support
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
The salary range for this role is $142500.00 - $256500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individuals position within the salary range will be based on several factors including but not limited to specific competencies relevant education qualifications certifications experience skills performance and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure 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 people are the driving force behind our scientific progress and our culture. Together 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.
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.
Our Working Model
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.
Moderna is a smoke-free alcohol-free and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Accommodations
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 accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation 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 team at .
Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NH1-
Required Experience:
Director
About Company
Learn how we’re changing the world of medicine. Discover career opportunities, our product pipeline, and browse media resources. Meet Moderna.