What are the responsibilities and job description for the Associate Director, Regulatory Data Management & Intelligence position at BioSpace?
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 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. That’s why our benefits and well-being resources are designed to support you—at 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, 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.
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 modernatx.com/careers 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 person's 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.
We’re 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 leavesandaccommodations@modernatx.com.
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 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. That’s why our benefits and well-being resources are designed to support you—at 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, 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.
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 modernatx.com/careers 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 person's 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.
We’re 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 leavesandaccommodations@modernatx.com.