The Role:

As Regulatory CTA Lead, you will oversee and provide operational and regulatory support for worldwide Clinical Trial Applications (CTAs), excluding the US IND. Key responsibilities include CRO oversight, coordination of CTA submissions to Health Authorities, management of regulatory databases, and ensuring compliance with country-specific CTA requirements. In addition, you will serve as a strategic regulatory subject matter expert supporting the planning, execution, and maintenance of clinical trial activities in the United Kingdom.

Here’s What You’ll Do:

• Leads and manages global Clinical Trial Application (CTA) activities outside the US

• Partners with Global Regulatory Leads (GRLs) to ensure aligned program strategies across regions

• Coordinates CROs to support timely CTA delivery

• Oversees preparation, review, and execution of submission packages, timelines, and operational plans

• Manages sponsor-side administration within regulatory platforms such as CTIS, IRAS, and Veeva RIM, ensuring accurate tracking, submission management, and record completeness

• Oversees regulatory query management, including coordination of responses and timely resolution with Health Authorities

• Maintains high-quality regulatory documentation and dossier management practices to support compliance and audit readiness

• Drives end-to-end CTA operational execution, including cross-functional coordination and submission tracking across global regions

• Independently identifies and escalates CTA regulatory risks, evaluates operational implications, and recommends solutions to GRLs and cross-functional stakeholders

• Serve as subject matter expert on UK regulatory frameworks, including MHRA expectations, the new UK Clinical Trials legislation and all evolving UK Clinical landscape

• Serve as MHRA-facing representative of Moderna for Clinical Trial related activities

Here’s What You’ll Need (Basic Qualifications) 

• At least bachelor’s degree in life science or related discipline

• 8+ years of experience in the pharmaceutical industry

• 5+ years of experience in Regulatory CTA

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

• Experience in direct interaction with Health Authorities and/or Ethics Committees

• 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.  That’s why our benefits and well-being resources are designed to support you—at 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
• Savings and investments 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, the infrastructure 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 people are the driving force behind our scientific progress and our culture. Together, 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 modernatx.com/careers 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 person's 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. 

We’re 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 [email protected]. 

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