Associate Director, Labeling Operations - Artwork

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions, meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

Moderna is seeking an experienced and forward-looking regulatory labeling professional to join our Global Regulatory Labeling Operations team. Reporting to the Sr. Director, Global Regulatory Labeling Operations, the Associate Director will be responsible for driving the timely creation, review, and approval of packaging and labeling artwork with a strong emphasis on process improvement, software implementation, and cross-functional collaboration. This role is pivotal in ensuring that Moderna’s container labeling is globally compliant and effectively supports commercial and regulatory strategies across international markets. With a global remit—particularly focused on the EU, Canada, Australia, Japan, and Latin America—this individual will serve as a subject matter expert in the evolving landscape of regulatory labeling, ensuring operational excellence and scalability in line with Moderna’s growth and impact.

Here’s What You’ll Be Doing:

Your key responsibilities will be:

• Oversee the global packaging and labeling artwork creation, review, and approval process across markets.

• Act as the primary interface between Global Regulatory Labeling and Supply Chain to support new artwork development and change approvals.

• Lead the implementation of an improved artwork management process, including associated procedures and software solutions.

• Serve as the labeling expert on Global Regulatory Sub Teams (GRSTs) in support of container labeling for regulatory submissions.

• Communicate current labeling regulations and standards clearly to cross-functional stakeholders, ensuring timely alignment and compliance.

Your responsibilities will also include:

• Contribute to the labeling control process by tracking and implementing changes to existing container labeling.

• Collaborate with Commercial, Quality Assurance, Regulatory Strategy, and Legal to ensure labeling strategy and operations are aligned with global product plans.

• Evaluate and introduce new technologies, workflows, and systems that can digitize and optimize the end-to-end labeling process.

• Maintain a strong external industry presence by monitoring emerging trends and influencing the labeling landscape through thought leadership.

• Ensure process scalability and operational readiness as the product portfolio and geographic footprint continue to expand.

The key Moderna Mindsets you’ll need to succeed in the role:

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  Your leadership in implementing a new artwork management process and software aligns directly with this mindset. You’ll play a key role in transforming how labeling operations are digitized across Moderna’s global footprint.

• We behave like owners. The solutions we’re building go beyond any job description.
  This role requires a proactive and strategic mindset—someone who takes ownership of challenges across labeling operations and drives solutions that support Moderna’s commercial, regulatory, and global access objectives.

Here’s What You’ll Bring to the Table:

• Bachelor’s degree required; Advanced degree preferred

Experience:

• At least 7-10 years of relevant experience in the pharmaceutical industry with preferably 6+ years in Regulatory Affairs and specific experience in labeling

• Ability to manage multiple projects in a fast-paced environment and drive them to completion

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

• Proven ability to flexibly support demanding operations timelines without compromising compliance in a challenging environment

• Proficiency in Microsoft Office and document management systems

• Experience with artwork approval processes and systems continuous improvement

• Experience in a GMP environment is required

• Experience in biotech or pharmaceutical environment is required

Specific skills:

• 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 for self and others

• Achievement/Result Orientation: a commitment to working to meet/exceed objectives and deliverables

• Strategic orientation: ability to link company and departmental visions with daily work

• Relationship building, teamwork and cooperation: build and maintain strong working relationships with colleagues

Problem solving:

• Analytical thinking: understand a situation or complex information by breaking it into small parts to better understand and solve problems

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments
• 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 [email protected]. 

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