Manager, Global Regulatory Science CTA at Moderna

Warsaw, mazowieckie, Poland -

Full Time

Start Date

Immediate

Expiry Date

05 Sep, 26

Salary

0.0

Posted On

07 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Applications, Regulatory Compliance, CTA Submission, MHRA Regulations, EU Regulation 536/2014, Veeva RIM, CTIS, IRAS, CRO Management, Regulatory Strategy, Dossier Management, Query Management, Cross-functional Collaboration, Digital Regulatory Operations, AI-enabled Tools, English Proficiency

Industry

Biotechnology Research

Description

If you’re interested in this role, please apply in English and include an English version of your Resume/CV. 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 Moderna’s 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. Here's What You'll Do: Lead and manage global Clinical Trial Application (CTA) activities outside of the US IND framework across Moderna's 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 Moderna’s 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 you’ll need to succeed in the role: “We obsess over learning. We don’t 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.” Here’s What You’ll Need (Basic Qualifications) At least bachelor’s 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. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class 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 leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Lead the operational execution of Clinical Trial Applications (CTAs) globally outside the US, with a specific focus on the UK regulatory landscape. Coordinate with Global Regulatory Leads and CROs to ensure submission excellence and compliance across multiple development programs.