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 establishing a significant presence at Harwell, the UK's globally recognized science and innovation campus. We’re looking for professionals who want to be part of a dynamic, cutting-edge environment that integrates science, technology, and collaboration to support our mission of transforming medicine. Harwell offers a unique opportunity to contribute to our growth while being immersed in a vibrant scientific community.

Moderna is seeking an innovative and forward-thinking Associate Director, Global Regulatory Labeling Operations, to drive the end-to-end development and lifecycle management of global container labeling components. Reporting to the Senior Director of Global Regulatory Labeling Operations, you will own and evolve the packaging and labeling artwork creation, review, and approval process within Global Regulatory Labeling. Your focus will center on launching and maintaining high-quality labeling for global markets—including the EU, Canada, Australia, Japan, and Latin America—through seamless cross-functional collaboration.

This individual contributor role offers a unique opportunity to embed labeling excellence early in our evolving infrastructure. You'll help define the framework for future artwork systems, build strong bridges with Supply Chain, Quality, Legal, and Regulatory Strategy teams, and provide critical support to Moderna's global expansion. Your work will be instrumental in enabling rapid and compliant access to mRNA-based medicines across diverse health systems.

Here’s What You’ll Be Doing:

Your key responsibilities will be:

• Leading the development, review, and approval of packaging and labeling artwork across multiple global markets.

• Serving as a key liaison with Supply Chain and other functions to ensure timely execution of new artwork development and changes.

• Driving implementation and ongoing optimization of new artwork management processes and software systems.

• Ensuring compliance with international regulatory requirements for container labeling through robust procedures and stakeholder communication.

• Participating in global regulatory sub teams (GRSTs) to ensure labeling is aligned with strategy and submission readiness.

Your responsibilities will also include:

• Acting as the labeling subject matter expert to advise on evolving regional regulations and industry standards.

• Contributing to the end-to-end labeling control process, including tracking and implementing updates to existing components.

• Collaborating with Commercial, QA, Legal, and Regulatory Strategy teams to maintain a harmonized and agile labeling process.

• Supporting readiness and inspection activities by maintaining documentation and systems to meet health authority expectations.

• Engaging with external industry peers to bring in best practices and advocate for modern regulatory labeling approaches.

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.”
  This role will lead the implementation of new artwork software solutions and process automation to modernize the labeling lifecycle, enabling Moderna to bring therapies to patients faster and more compliantly.

• “We obsess over learning. We don’t have to be the smartest—we have to learn the fastest.”
  Global labeling is constantly evolving. Success in this role depends on staying ahead of global regulatory changes, adopting new technologies, and sharing learnings across teams to strengthen Moderna’s worldwide impact.

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

Education:

• 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.