Manager, Global Regulatory Science CTA

ModernaMultiple locationsonsiteSalary not postedView the original posting at Moderna ↗

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. Based in Warsaw as an individual contributor, you will lead worldwide Clinical Trial Application (CTA) operations outside the United States, excluding US Investigational New Drug (IND) submissions. You will provide operational and regulatory support across global programs, connecting cross-functional teams, contract research organizations (CROs), and Health Authority submission activities while ensuring compliance with country-specific CTA requirements. Your remit will also include Development Safety Update Report (DSUR) submission oversight and supporting the creation of Development Medicinal Products in the xEVMPD system. Here’s What You’ll Do: Lead end-to-end global CTA operations outside the US, coordinating cross-functional activities and submission tracking across regions. Bring together operational planning, regulatory requirements, and execution to support timely, compliant submissions to Health Authorities. Partner with Global Regulatory Leads (GRLs) to ensure program strategies are aligned across regions and reflected in CTA submission plans, timelines, and operational priorities. Oversee and coordinate CROs to support timely CTA delivery, aligning submission activities and deliverables with program needs and maintaining clear visibility of progress across global regions. Oversee the preparation, review, and execution of CTA submission packages, managing associated timelines and operational plans. Coordinate cross-functional inputs and delivery to Health Authorities, ensuring packages meet country-specific CTA requirements. Manage regulatory databases and sponsor-side administration within CTIS, IRAS, and Veeva RIM, ensuring accurate tracking, effective submission management, and complete regulatory records throughout CTA execution. Oversee regulatory query management, coordinating cross-functional and CRO contributions to Health Authority responses and driving timely resolution while maintaining alignment with the relevant program strategy. Maintain high-quality regulatory documentation and dossier management practices, supporting compliance, record completeness, and audit readiness across global CTA activities. Support the cross-functional team with DSUR submission oversight, coordinating relevant operational inputs and monitoring submission progress to support timely delivery. Support the creation of Development Medicinal Products in the xEVMPD system, working with cross-functional colleagues to ensure the associated regulatory information is accurately captured. The key Moderna Mindsets you’ll need to succeed in the role: " We act with dynamic range, driving strategy and execution at the same time at every step.” You will connect program-level regulatory strategy with detailed operational execution, moving between global stakeholder coordination, CRO oversight, submission planning, and regulatory query resolution. Success means maintaining a clear view of program objectives while ensuring the accuracy and completeness of each submission and regulatory record. “We digitize everywhere possible using the power of code to maximize our impact on patients.” You will apply a digital mindset to regulatory systems, information quality, and submission management. This includes exploring opportunities to work with generative AI tools to support regulatory information retrieval, document workflows, and operational tracking, with appropriate human review, confidentiality safeguards, and attention to applicable regu

Tools named in this posting

veeva vault rim

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