Moderna
Biotech
Manager,GlobalRegulatoryScienceCTA
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager, Global Regulatory Science CTA at Moderna. Skills: Regulatory science, CTA management, Global submissions. Manage global regulatory submissions. Develop regulatory strategies”
What You'll Achieve.
Ensure timely submission of CTAs; Maintain regulatory compliance
Industry & Context.
Regulatory problem solving
What They're Looking For.
Must Have
5+ years of experience in regulatory affairs, Bachelor's degree in a scientific discipline, Experience with global regulatory submissions
Nice to Have
Master's or PhD degree, Experience in biologics or advanced therapies, Experience with regulatory strategy development
What You'll Do.
Manage global regulatory submissions
Develop regulatory strategies
Ensure compliance with regulations
Author and review regulatory documents
Liaise with health authorities
Provide regulatory guidance to project teams
Monitor regulatory intelligence
Support regulatory filings
How You'll Work.
Team & Collaboration
Cross-functional teams; Health authorities; Project teams
Communication Scope
Regulatory communication
Process & Methodology
Project management
Full Job 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 deve
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