Manager, Regulatory Science, EEMEA

Manager, Regulatory Science, EEMEA page is loaded Manager, Regulatory Science, EEMEAlocations: London - England: Clinical Developmenttime type: Full timeposted on: Posted Todaytime left to apply: End Date: October 31, 2025 (30+ days left to apply)job requisition id: R18208 The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its presence in London, a global hub for scientific research and innovation. Our London office focuses on commercial operations, ensuring the delivery of our revolutionary products to the UK market. We're seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.In this role, you will be instrumental in shaping and driving regulatory strategies for the Eastern Europe, Middle East, and Africa (EEMEA) region. You will partner closely with the Director of Regulatory Affairs - EEMEA, global regulatory teams, and cross-functional stakeholders to ensure smooth regulatory execution across Moderna's pipeline and marketed products. This is a unique opportunity to work with Health Authorities across diverse markets, supporting both early development and lifecycle management of mRNA medicines. You will act as a trusted regulatory advisor, managing submissions, post-approval activities, and risk assessment while representing Moderna's pioneering science externally. By combining strong technical knowledge with collaboration, you will help Moderna navigate complex regulatory pathways and deliver on its mission of transforming patient outcomes. This is an individual contributor role based in London, with a remit spanning the EEMEA region. Here's What You'll Do: Your key responsibilities will be: Lead regulatory aspects of assigned projects and programs across EEMEA. Support the Director, Head of Regulatory Affairs - EEMEA, Global Regulatory Teams, and Regional/Country Cross-Functional Teams in developing and executing regulatory strategies. Contribute to and oversee the preparation of regulatory submissions, including dossiers, meeting requests, orphan-drug designations, priority review applications, safety reports, and RTQs. Manage post-approval lifecycle activities and commitments of approved products in EEMEA. Your responsibilities will also include: Anticipating and addressing regulatory challenges associated with mRNA as a new drug modality. Maintaining close contact with Health Authorities and partner regulatory teams/consultants. Identifying and assessing regulatory risks for assigned programs. Preparing and delivering effective communications and presentations for internal and external stakeholders. Providing cross-functional regulatory guidance across Moderna's business activities, from IND through lifecycle management. 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. - Regulatory science in EEMEA requires agility and constant learning to adapt to evolving frameworks and diverse authority expectations. We act with urgency; Action today compounds the lives saved tomorrow. - Timely, proactive regulatory engagement is critical to accelerating access to Moderna's transformative mRNA medicines for patients across EEMEA. Here's What You'll Bring to the Table: BA/BS degree in a scientific major (eg. Biology, Biochemical, Bioengineering, Pharmacy) required. 10+ years of experience in the Pharmaceutical industry 7+ years of experience in Regulatory Affairs Strong knowledge of current EEMEA and International regulations including the US and the EU, related to the clinical, nonclinical, and CMC development of biologic products Strong experience with CTD format and content of regulatory filings Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in EEMEA Able to help create and maintain parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements Ability to work independently to manage multiple projects in a fast-paced environment Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones Able to effectively communicate the regulatory strategy, risks, mitigation and overall plans to Project Teams and senior management, as relevant Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Business level fluency in English is required. Fluency in Arabic is an advantage. A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative 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. Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments Location-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free, and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is committed to equal opportunity in employment