Senior Manager, Global Regulatory Labeling

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.

This is a Warsaw-based individual contributor role for a forward-thinking regulatory labeling professional ready to elevate the operational execution of global labeling for an innovative biotech pipeline. Moderna is seeking a Senior Manager Global Regulatory Labeling Operations who will drive the preparation and maintenance of product labeling in compliance with global regulatory requirements with a specific focus on expanding into Middle Eastern and Asia Pacific markets. As part of our Global Regulatory Affairs organization the role ensures timely submission and oversight of labeling content acts as a key point of contact for cross-functional labeling initiatives and plays an integral part in the development of core labeling documents. This is a strategic and hands-on opportunity to influence Modernas global labeling footprint and work at the cutting edge of regulatory science.

Heres What Youll Do:

Your key responsibilities will be:

• Apply deep understanding of international labeling regulations and standards and advise internal stakeholders to ensure compliance across labeling deliverables.

• Contribute to the operational control and tracking of labeling changes from development through submission and approval stages.

• Drive the development of new prescribing information in alignment with regional regulatory expectations especially for Middle East and Asia Pacific regions.

• Collaborate with Regulatory Strategy Leads to craft labeling text aligned with Core Company Data Sheets (CCDS) and product strategy.

• Ensure consistency and compliance of global and local labeling processes through alignment with cross-functional Project Teams.

Your responsibilities will also include:

• Manage submission of labeling components and supporting documents to global health authorities in accordance with regulatory frameworks.

• Serve as the labeling representative in Global Regulatory Affairs Sub Teams (GRSTs) to support submission activities.

• Support labeling-related change controls by gathering documentation and maintaining compliance within the electronic document management system.

• Oversee the end-to-end labeling lifecycle ensuring accuracy timeliness and regulatory readiness.

• Monitor and engage with evolving global labeling trends and contribute to industry influence on labeling standards.

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.
  This role requires a strong understanding of electronic systems and document management platforms to drive regulatory labeling processes. Youll be expected to embrace digital tools that enhance efficiency and compliance throughout the labeling lifecycle.

• We act with urgency; Action today compounds the lives saved tomorrow.
  Labeling timelines are critical in the successful delivery of medicines to global markets. Your ability to operate with speed precision and foresight will directly support patient access and global health outcomes.

Heres What Youll Bring to the Table:

• Bachelors degree required; Advanced degree preferred

• At least 5-8 years of relevant experience in the pharmaceutical industry with preferably 5 years in Regulatory Affairs and specific experience in labeling

• Extended knowledge of science and data of assigned products and how that translates into labeling language.

• Hands-on assistance with the delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA etc.)

• Experience facilitating meetings and driving consensus and results.

• Excellent leadership communication (verbal and writing) and collaboration skills.

• Proven ability in medical/technical writing.

• Labeling experience (CCDS US EU) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.

• 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 Modernas vision and strategic objectives with daily work.

• Communication: ability to effectively convey information to a variety of audiences. Specifically interacts effectively as member of the GRSTs and collaborates effectively with business partners including affiliates and third parties.

• Flexibility/adaptability: ability to adapt to and work effectively within a variety of situations and with various individuals or groups.

• Relationship building teamwork and cooperation: builds and maintains collaborative relationships with people and demonstrates desire to work well with others.

• 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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