Manager, Regulatory Science, EEMEA

Overview

The role focuses on 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. This is an individual contributor role based in London, with a remit spanning the EEMEA region.Responsibilities

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.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.Able to effectively communicate the regulatory strategy, risks, mitigation and overall plans to Project Teams and senior management, as relevant.Qualifications

BA/BS degree in a scientific major (e.g., 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 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). 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.Benefits

Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investmentsLocation-specific perks and extrasAbout Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are the driving force behind our scientific progress and our culture. 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. Moderna champions in-person collaboration with a 70/30 in-office work model to foster innovation, teamwork, and mentorship.Equal Opportunity

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Qualified applicants will be considered regardless of criminal histories, consistent with legal requirements. Moderna is also committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. If you require an accommodation in the hiring process or to perform the essential functions of the position, contact the Accommodations and Adjustments team at ..... full job details .....