Submission Manager, Regulatory Operations

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 role, you will sit at the center of global regulatory operations, orchestrating the planning, management, and execution of complex submission strategies. You will partner closely with Regulatory Leads and cross-functional teams to deliver high-quality submissions to health authorities worldwide, ensuring precision, compliance, and speed. This is a highly visible individual contributor role where your expertise will directly influence the success of global regulatory filings and lifecycle management. Here's What You'll Do: Manage the development and maintenance of comprehensive submission content plans, tracking documents from authoring through approval, publishing, and quality control. Serve as the global submissions' expert, guiding teams on e-submission standards (eCTD, NeeS, etc.) and lifecycle management, while clearly communicating regional regulatory differences. Partner with Regulatory Leads to plan and prepare high-quality global submissions, executed internally or through CROs, ensuring timely delivery to global health authorities. Provide clear communication of project status, risks, timelines, and milestones to stakeholders and senior management. Deliver operational oversight across the full submission lifecycle, including planning, preparation, publishing, validation, and submission of INDs, NDAs, MAAs, amendments, updates, and variations. Manage external publishing vendors to ensure the creation and timely delivery of high-quality regulatory submission packages. Maintain deep technical expertise in evolving regulatory requirements, ensuring alignment with internal processes and external expectations. Act as a subject matter expert for Moderna’s document management systems, driving efficient and compliant document workflows. Compile and coordinate regulatory submissions, ensuring accurate and timely distribution to health authorities and CRO partners. Oversee submission and product lifecycle information, ensuring data integrity and accessibility across systems. Lead and contribute to special projects, bringing operational excellence and continuous improvement to regulatory processes. Act as the primary point of contact for major submissions, providing guidance, structure, and leadership across submission teams. Drive urgency in execution, ensuring all submissions meet critical global health authority deadlines. Leverage digital tools and platforms to enhance submission efficiency, quality, and scalability, including opportunities to work closely with emerging generative AI-enabled solutions in regulatory operations. The key Moderna Mindsets you’ll need to succeed in the role: We act with urgency: Your timely management of submissions will be critical to meeting global health authorities' deadlines. We prioritize the platform: Utilizing digital tools and systems will enhance submission efficiency and accuracy. 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, sabbati ... (truncated, view full listing at source)