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.
Reporting to the Sr. Director of Global Regulatory Labeling Operations, you will lead packaging and labeling artwork creation, review, approval, and implementation activities for assigned Rest of World (ROW) markets, with particular focus on countries across Latin America and the Asia Pacific region.
As an individual contributor and regulatory labeling subject matter expert, you will navigate the regulatory and operational complexity of rapidly delivering compliant container labeling outside the major markets, connecting regulatory requirements with artwork execution and supply implementation.
Working across Supply Chain, Commercial, Quality Assurance, Regulatory Strategy, Legal, Global Regulatory Science teams, and other partners, you will drive multiple concurrent labeling initiatives while helping evolve the processes, systems, software, and digital capabilities—including opportunities to work with Generative AI-enabled tools—that support scalable global labeling operations.
Here’s What You’ll Do
•Serve as a subject matter expert on applicable labeling regulations and industry standards for container labeling, interpreting requirements and providing clear guidance to cross-functional stakeholders across assigned ROW markets.
•Lead and manage the creation, review, approval, and implementation of new and revised packaging and labeling artwork, partnering closely with Supply Chain colleagues and other stakeholders to move changes efficiently and compliantly through the end-to-end process.
•Manage and drive labeling control activities for the tracking and implementation of changes to existing labeling within your assigned scope, maintaining visibility of activities, dependencies, risks, and implementation status.
•Support existing and new labeling processes and software, helping ensure that operational capabilities continue to meet evolving regulatory, business, and compliance requirements.
•Lead or contribute to enhancements of labeling processes, systems, and tools, identifying opportunities to improve efficiency, compliance, scalability, and digital enablement.
•Explore appropriate opportunities to work with Generative AI-enabled and other advanced digital tools within labeling operations, supporting responsible approaches that can improve information synthesis, workflow efficiency, and operational decision-making while maintaining required regulatory and quality controls.
•Partner with cross-functional Project Teams to drive consistent application of labeling processes and resolve artwork, approval, and implementation issues.
•Serve as the Labeling expert within Global Regulatory Science sub-teams (GRSTs) for activities related to the development of container labeling for regulatory submissions, connecting submission strategy with downstream artwork and implementation requirements.
•Identify and recommend improvements to the end-to-end labeling process, partnering with stakeholders to support effective implementation and sustainable adoption.
•Work extensively across functions including Supply Chain, Commercial, Quality Assurance, Regulatory Strategy, Legal, and other relevant teams to align regulatory requirements, artwork execution, operational readiness, and implementation timing.
•Maintain knowledge of evolving and emerging pharmaceutical and biotechnology industry standards and trends through engagement within the industry, bringing relevant external developments into Moderna and helping influence the broader industry environment on labeling topics.
•Independently manage complex artwork and labeling operational issues within assigned ROW markets, assessing regulatory and operational risks, developing and recommending solutions, and escalating significant issues when appropriate.
•Manage multiple concurrent artwork initiatives across assigned ROW markets, establishing priorities, coordinating cross-functional dependencies, and driving activities through to timely and compliant completion.
•Apply experience gained within biotechnology, pharmaceutical, or another regulated environment to anticipate the challenges associated with delivering container labeling rapidly and compliantly across diverse international markets.
•Bring a forward-looking and creative approach to regulatory labeling operations, anticipating evolving requirements and developing practical solutions for markets outside the major regions, particularly across Latin America and Asia Pacific.
The key Moderna Mindsets you’ll need to succeed in the role:
•“We act with dynamic range, driving strategy and execution at the same time at every step.”
•“We remove viscosity to encourage collective action.”
Here’s What You’ll Need (Basic Qualifications)
•Bachelor’s degree required.
•At least 7 years of relevant experience in the pharmaceutical industry with preferably at least 5 years in Regulatory Affairs and specific experience in labeling
•Proficiency in English (verbal and/or written) required due to global collaboration needs.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
•Demonstrated ability to independently manage multiple complex projects in a fast-paced environment, establish priorities, coordinate cross-functional dependencies, and drive activities to timely completion.
•Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
•Proven ability to manage demanding operational timelines with flexibility and sound judgment without compromising quality or compliance in a challenging environment.
•Proficiency in Microsoft Office and document management systems, including electronic artwork management systems
•Experience in improving artwork approval processes and systems
•Experience in a GMP environment is required
•Experience in biotech or pharmaceutical environment is required
•Experience facilitating meetings and driving consensus and results.
•Excellent leadership, communication (verbal and writing) and collaboration skills.
•Integrity: overriding commitment to integrity and high standards in self and others.
•Achievement/Results Orientation: a commitment to working well to meet/exceed objectives and deliverables
•Strategic orientation: ability to link company and department visions with daily work
•Relationship building, teamwork and cooperation: builds or maintains collaborative relationships with team members.
•Analytical thinking: understand a situation or complex information by breaking it apart into small parts to better understand and solve problems.
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.
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
•Savings and investments 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.
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 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 .
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