Manager, Global Regulatory Science, CTA Coordinator

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 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 Modernas 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 Modernas expanding global clinical trial footprint and you will be close to cutting-edge developments in the regulatory use of Generative AI and digital systems.

Heres What Youll 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 youll need to succeed in the role:

• We behave like owners. The solutions were 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.

Heres What Youll 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)

• Regulatory submission experience and expertise in regulatory requirements systems and working practices

• Good project management experience and leadership skills

• Excellent knowledge of English spoken and written

• Proven ability to work within multi-functional teams building strong and productive relationships across an organization.

• A desire to be part of a high-growth transformational company that is Bold Relentless Curious and Collaborative

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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