Senior Manager, Global Regulatory Labeling

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.

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 Moderna’s global labeling footprint and work at the cutting edge of regulatory science.

Here’s What You’ll 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 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 requires a strong understanding of electronic systems and document management platforms to drive regulatory labeling processes. You’ll 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.

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

• Bachelor’s 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