Associate Director, Labeling Operations, Artwork

Moderna; Oxford; On-site; GBP 80,000 - 110,000; Full time

Job summary

A leading biotechnology firm in Oxford is seeking an Associate Director, Global Regulatory Labeling Operations. You will manage the global labeling processes to ensure compliance with international regulatory standards while collaborating with cross-functional teams. Ideal candidates should have 7-10 years in the pharmaceutical industry and strong leadership skills. This role offers the opportunity to significantly impact patient access to mRNA-based medicines in a pioneering environment.

Benefits

Quality healthcare and insurance benefits

Generous paid time off

Free premium access to fitness and wellness classes

Qualifications

• 7-10 years of experience in the pharmaceutical industry, including 6+ years in Regulatory Affairs.
• Ability to manage multiple projects effectively in a fast-paced environment.
• Experience in a GMP environment.

Responsibilities

• Lead development and approval of packaging and labeling artwork.
• Ensure compliance with international regulatory requirements.
• Act as subject matter expert for regional regulations.

Skills

Leadership

Communication

Analytical thinking

Project management

Collaboration

Education

Bachelor’s degree

Advanced degree

Tools

Microsoft Office

Document management systems

Job description

Overview

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.

Responsibilities

Here’s What You’ll Be Doing:

• 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.

Key Moderna Mindsets

• “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.

Qualifications

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
• Savingsandinvestments
• 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 Moderna’s careers page 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 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 [e-mail].

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