Associate Director, Labeling Operations Artwork

The Role:

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

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

Modernas 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 Modernas global business operations. Were 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 Modernas container labeling is globally compliant and effectively supports commercial and regulatory strategies across international markets. With a global remitparticularly focused on the EU Canada Australia Japan and Latin Americathis individual will serve as a subject matter expert in the evolving landscape of regulatory labeling ensuring operational excellence and scalability in line with Modernas growth and impact.

Heres What Youll 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 youll 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. Youll play a key role in transforming how labeling operations are digitized across Modernas global footprint.

• We behave like owners. The solutions were building go beyond any job description.
  This role requires a proactive and strategic mindsetsomeone who takes ownership of challenges across labeling operations and drives solutions that support Modernas commercial regulatory and global access objectives.

Heres What Youll Bring to the Table:

• Bachelors degree required; Advanced degree preferred

Experience:

• At least 7-10 years of relevant experience in the pharmaceutical industry with preferably 6years 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. Thats why our global benefits and well-being resources are designed to support youat 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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 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 persons 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.

Were 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 .

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