Senior 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.

You will be a pivotal member of Modernas Global Regulatory Science (GRS) team responsible for ensuring the compliant timely and high-quality execution of Clinical Trial Application (CTA) submissions across a global portfolio of studies. Operating from our Warsaw office this individual contributor role places you at the heart of Modernas international regulatory operations collaborating cross-functionally with Clinical Development Clinical Operations Safety and CMC functions. You will drive the global CTA strategy while also enhancing Modernas regulatory processes and knowledge base particularly within the European context. This role offers significant opportunity to engage with evolving regulatory frameworks and interface with Generative AI tools used across Modernas digital-first operating model.

Heres What Youll Do:

Your key responsibilities will be:

• Overseeing regulatory submissions of Clinical Trial Applications (CTAs) globally ensuring quality and strategic alignment.

• Guiding and coordinating the CTA dossier compilation especially around Module 1 content including administrative forms translations and artwork where required.

• Leading cross-functional regulatory submission activities with internal stakeholders and Contract Research Organizations (CROs).

• Providing direct submission support to Health Authorities or guiding in-country personnel through the CTA process.

Your responsibilities will also include:

• Driving implementation and continuous refinement of global CTA submission strategies throughout the clinical trial lifecycle.

• Ensuring compliance with mandatory and country-specific regulatory requirements.

• Leading cross-functional alignment across Clinical CMC Safety and Regulatory teams to support investigational medicinal product development.

• Managing regulatory knowledge sharing with a focus on European regulations and evolving guidelines impacting CTA and lifecycle management.

• Organizing and delivering training on regulatory changes to cross-functional teams.

• Initiating and leading process improvements within GRS and Modernas International HQ.

• Maintaining an effective system for archival submission tracking approval records and Health Authority Q&A to promote organizational learning.

The key Moderna Mindsets youll need to succeed in the role:

• We obsess over learning. We dont have to be the smartest we have to learn the fastest.
  This mindset is critical for staying current with regulatory requirements especially in the dynamic landscape of European clinical trial legislation. Your proactive learning approach will support successful submissions and compliance across multiple geographies.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  You will benefit from Modernas digital-first approach leveraging advanced digital systemsand opportunities to interact with Generative AI toolsto streamline submission workflows enhance data quality and improve overall efficiency in regulatory operations.

Heres What Youll Bring to the Table:

• Degree in Life Science or related discipline

• 7 years of experience in the Pharmaceutical industry.

• 5 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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