Manager, Global Regulatory Science CTA

About 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, C