Manager, Global Regulatory Science CTA

The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening its international business services hub in Warsaw supporting our growing global operations. We welcome professionals ready to help advance our mission and shape the future of mRNA medicines.

In this highly visible global regulatory role you will lead the operational execution of Clinical Trial Applications (CTAs) worldwide outside of the United States while serving as Modernas subject matter expert for the evolving United Kingdom clinical trial regulatory landscape. Working across multiple development programs and regions you will drive submission excellence regulatory compliance and operational effectiveness to enable the timely advancement of innovative medicines to patients.

As a key partner to Global Regulatory Leads clinical teams CROs and regulatory stakeholders you will combine strategic regulatory expertise with hands-on operational leadership ensuring seamless CTA planning submission maintenance and Health Authority interactions across global markets. You will also have the opportunity to leverage advanced digital platforms automation capabilities and emerging AI-enabled tools to enhance regulatory operations data quality and submission efficiency.

Heres What Youll Do:

• Lead and manage global Clinical Trial Application (CTA) activities outside of the US IND framework across Modernas worldwide clinical development portfolio.

• Provide operational and regulatory support for worldwide CTAs ensuring compliance with applicable country-specific regulatory requirements.

• Partner closely with Global Regulatory Leads (GRLs) to ensure alignment of regulatory strategies and execution plans across regions and development programs.

• Coordinate and oversee Contract Research Organizations (CROs) ensuring high-quality and timely CTA deliverables.

• Lead the preparation review and execution of CTA submission packages submission timelines and operational plans.

• Drive end-to-end CTA operational execution ensuring effective cross-functional collaboration and submission tracking across global regions.

• Manage sponsor-side administration and oversight within regulatory platforms including CTIS IRAS and Veeva RIM.

• Ensure accurate submission tracking regulatory record management document completeness and system compliance across regulatory databases.

• Oversee regulatory query management activities coordinating responses and facilitating timely resolution of Health Authority questions.

• Maintain high-quality regulatory documentation dossier management practices and inspection-ready records to support compliance and audit readiness.

• Monitor and drive adherence to global CTA processes timelines and regulatory commitments.

• Serve as Modernas regulatory subject matter expert for the United Kingdom clinical trial environment.

• Provide strategic guidance on MHRA expectations UK Clinical Trial Application requirements and evolving UK clinical trial regulations.

• Support the planning execution maintenance and lifecycle management of clinical trial activities within the United Kingdom.

• Maintain awareness of emerging regulatory developments including the new UK Clinical Trials legislation and the evolving UK clinical research landscape translating changes into actionable regulatory strategies.

• Collaborate across regulatory clinical quality and operational teams to proactively address regulatory risks and enable efficient study execution.

• Contribute to continuous improvement initiatives that strengthen regulatory operations through digitization process optimization and innovative technologies including AI-enabled approaches where appropriate.

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.

• We digitize everywhere possible using the power of code to maximize our impact on patients.

Heres What Youll Need (Basic Qualifications)

• At least bachelors degree in life science or related discipline

• 5 years of experience in the pharmaceutical industry.

• 4 years of experience in Regulatory CTA

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

• Hands-on experience with the combined UK CTAs via IRAS will be considered a strong asset

• Good understanding of the Regulation (EU) 536/2014 and Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025

• 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

• Proficiency in English (verbal and/or written) required due to global collaboration needs

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our benefits and well-being resources are designed to support youat work at home and everywhere in between.

• Competitive healthcare plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness mindfulness and mental health support
• Family building benefits including fertility adoption and surrogacy support
• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savingsandinvestments to help you plan for the future
• 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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