Manager, Global Regulatory Science, CTA Coordinator

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 individual contributor role offers an exceptional opportunity to provide end-to-end regulatory operational support across global Clinical Trial Applications (CTAs). Based in Warsaw, you will play a critical role in coordinating and submitting regulatory dossiers to national Health Authorities, while driving compliance and process optimization. You will support all stages of the CTA lifecycle and serve as the operational point of contact for both internal teams and external CROs. You will also be a key contributor to Moderna’s regulatory strategy, particularly in Europe, helping to ensure that regulatory submissions are timely, high-quality, and aligned with evolving international standards. This role is pivotal in supporting Moderna’s expanding global clinical trial footprint, and you will be close to cutting-edge developments in the regulatory use of Generative AI and digital systems.

Here’s What You’ll Do:

Your key responsibilities will be:

• Oversee the regulatory submission of Clinical Trial Applications (CTAs) to national Health Authorities worldwide.

• Guide the coordination and compilation of CTA dossiers, especially Module 1 (e.g., administrative forms, translation management, artwork coordination).

• Support direct submissions to Health Authorities or facilitate local submissions in collaboration with in-country personnel.

• Liaise with and provide oversight to Contract Research Organizations (CROs) for CTA submission and query management.

• Maintain effective tracking records for submissions, approvals, and regulatory correspondence, ensuring learning is retained and shared internally.

Your responsibilities will also include:

• Drive implementation of the global CTA submission strategy and ensure consistency and quality across submissions.

• Ensure all country-specific regulatory requirements are in place for CTA compliance or other submissions.

• Serve as an operational partner to cross-functional stakeholders in Clinical Development, Clinical Operations, Safety, CMC, and Regulatory.

• Maintain up-to-date expertise in EU regulatory frameworks, particularly around clinical trials and novel regulatory initiatives.

• Communicate key regulatory changes and updates to internal stakeholders and guide operational strategy accordingly.

• Lead and contribute to process improvement initiatives across Global Regulatory Science (GRS) and International HQ teams.

The key Moderna Mindsets you’ll need to succeed in the role:

• We behave like owners. The solutions we’re building go beyond any job description.
  In this role, you will take ownership of complex global submissions and help shape regulatory systems, acting as a bridge between clinical strategy and execution.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  As Moderna embraces the frontier of digital innovation, including Generative AI, this role places you close to our digital transformation of regulatory processes — from submissions to analytics and tracking.

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

• Degree in Life Science or related discipline

• 5+ years of experience in the Pharmaceutical industry.

• 4+ years of experience in Regulatory

• Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union

• Good knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)

• Regulator