Submission Manager, Regulatory Operations

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. This is an opportunity to take ownership of the planning, management and tracking of high-quality regulatory submissions across Moderna’s global portfolio. As an individual contributor and global submissions expert, you will partner closely with Regulatory Leads and cross-functional teams to orchestrate submission content from authoring through approval, publishing, quality control and delivery to health authorities. You will bring deep regulatory operations expertise to major submissions, providing operational oversight across applications including INDs, NDAs and MAAs, as well as updates, amendments and variations. You will connect regulatory strategy with precise execution, ensuring teams understand eCTD, NeeS and lifecycle management requirements and the regional differences that shape global submission preparation. Working in a highly digital regulatory environment, you will also have opportunities to get close to Generative AI tools and explore how emerging technologies can support regulatory operations, while maintaining the compliance, quality and technical rigor required for global submissions. Here's What You'll Do: Manage the development and maintenance of detailed submission content plans, encompassing all source submission content—including documents and data—and track content through authoring, approval, publishing and QC. Serve as a global submissions expert, building project-team awareness and knowledge of electronic submission formats including eCTD and NeeS, lifecycle management concepts and relevant regional differences within global submission preparation. Provide regulatory operations expertise to cross-functional submission project teams and act as a primary point of contact for project and/or submission teams supporting major submissions. Partner with Regulatory Leads to plan and prepare high-quality global submissions, whether delivered in-house or through CRO partners, ensuring compliant submissions reach global health authorities within required timelines. Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications—including INDs, NDAs and MAAs—as well as updates, amendments and variations to regulatory agencies globally. Manage publishing vendor activities to support the preparation of high-quality submission packages and their timely delivery to health authorities. Effectively communicate project status, issues, schedules and accomplishments to management and stakeholder groups as required. Maintain technical expertise in regulatory requirements, ensuring alignment with Moderna processes and applicable client requirements. Act as a subject matter expert for Moderna’s document management system. Compile regulatory submissions and coordinate their distribution to all relevant parties, including health authorities and CROs, within agreed timelines. Manage submission and product lifecycle information throughout the regulatory process. Lead and manage special projects as required, bringing together stakeholders across Regulatory, Clinical, Nonclinical and other functions. Apply strong document formatting and troubleshooting capabilities across Microsoft Word and PDF Professional and use Microsoft PowerPoint to support effective stakeholder communication. Work within Moderna’s digital-first environment, gaining exposure to Generative AI tools and considering appropriate opportunities to enhance the efficiency and quality of

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