Director, Regulatory Science

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 presence in Paris, at the center of France’s biotech industry. Our team leads commercial operations to bring our mRNA medicines to patients across France. We welcome global talent committed to making a meaningful impact. This is an opportunity to lead regulatory strategy for Moderna’s French affiliate, shaping how our mRNA medicines progress through an evolving regulatory environment across Infectious Diseases, Oncology, Cardiovascular and Rare Diseases. As an individual contributor and subject to formal corporate designation, you will combine strategic regulatory leadership with the statutory responsibilities of Pharmacien Responsable, working directly with French authorities and cross-functional partners to protect patients, maintain compliance and enable Moderna’s business in France. You will operate at the intersection of local, European and global regulatory strategy, with opportunities to contribute to EU and international programs and to explore how Generative AI and emerging digital tools can support increasingly effective regulatory intelligence, content development and ways of working. Here's

What You'll Do
Lead regulatory strategy for the French affiliate, anticipating regulatory challenges and providing forward-looking, creative and agile guidance for Moderna’s mRNA therapeutics and vaccines. Lead regulatory interactions with local authorities and manage regulatory activities and marketing authorization applications for France. Serve as Pharmacien Responsable for Moderna’s pharmaceutical establishment in France, subject to formal corporate designation and continued fulfillment of all applicable French legal and professional requirements. Exercise the responsibilities assigned to the Pharmacien Responsable under the French Public Health Code, with the independence, authority and access to management necessary to protect public health and patient safety. Organize and oversee the pharmaceutical operations of the French entity, as applicable, including regulatory compliance, product information and advertising, pharmacovigilance interfaces, distribution, batch traceability and recall, and other activities falling within the statutory remit of the Pharmacien Responsable. Act as a key contact with ANSM and the French Order of Pharmacists for matters within the Pharmacien Responsable remit; support inspections, ensure appropriate pharmaceutical continuity and escalate issues that could compromise compliance, product quality, supply or patient safety. Provide regulatory leadership and support across Moderna’s Therapeutic Areas, including Infectious Diseases, Oncology, Cardiovascular and Rare Diseases. Work closely with the French affiliate business to provide regulatory guidance supporting overall business plans, including Health Technology Assessment activities. Support local business objectives and commercial execution from a regulatory perspective, including artwork review, promotional material review, regulatory training and updates for the local affiliate, and Market Access activities covering pricing, reimbursement and tenders. Collaborate effectively across the local affiliate, including with the General Manager, Commercial Strategy, Market Access, Pharmacovigilance, Quality Assurance and other functions, providing proactive regulatory input to business activities. Develop and contribute to the content, format and accountability of regulatory submissions, supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs and MAAs. Create and maintain France-specific regulatory dossier components and product information, including local labeling and packaging requirements, and support national implementation and lifecycle maintenance following EU regulatory procedures. Coordinate the regulatory submissions relevant to assigned projects and programs across the assigned territory. Identify and assess regulatory risks for assigned projects and programs, develop appropriate mitigations and communicate regulatory strategy, risks, mitigations and overall plans effectively to project teams and senior management. Contact and engage relevant regulatory agencies for assigned projects and programs, as appropriate. On selected projects, contribute to EU regulatory strategy as the International Regulatory Lead, partnering closely with Global Regulatory Leads and providing international regulatory strategy input throughout development. Provide strategic input into pediatric plans, scientific advice, PRIME and regulatory considerations spanning clinical, nonclinical and CMC development, as well as DSURs and MAAs. Partner with the VP, Regulatory Affairs – International and Global Regulatory Teams on the development and execution of regulatory strategies in the EU and international markets, potentially including Latin America. Prepare and deliver clear, effective communications and presentations for both internal and external audiences. Work independently while contributing effectively to project teams, committees and a dynamic cross-functional matrix environment to achieve business objectives and critical regulatory milestones. Bring strong knowledge of current French and European regulations governing innovative medicines, including vaccines, together with broad knowledge of regulatory procedures and legislation covering drug development, product registration, line extensions and license maintenance in the EU and international markets. Apply significant experience with CTD format and content and the preparation and maintenance of EU regulatory filings, including major regulatory submissions and supporting amendments or supplements. Manage multiple projects independently in a fast-paced environment while maintaining the precision and strategic judgment required for complex regulatory programs. Share regulatory knowledge and lessons learned through outstanding written and verbal communication, strengthening collaboration across local, regional and global teams. Explore opportunities to work with Generative AI and emerging digital capabilities to support regulatory intelligence, content workflows and efficient ways of working, while applying appropriate scientific, regulatory and human oversight 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.” “We question convention because proven models don’t always fuel the future.” Here’s What You’ll Bring to the Table: Qualified pharmacist eligible to practice in France and to be formally designated as Pharmacien Responsable, including satisfaction of applicable French Public Health Code requirements for professional registration and practical experience. Advanced scientific degree (e.g. PharmD, MSc, PhD) is a plus. 10+ years of experience in the Pharmaceutical industry. 8+ years of experience in Regulatory strategy Strong knowledge of current France/European regulations related to the regulatory requirements for innovative medicines, including vaccines Strong experience with CTD format and content and with preparation and maintenance of EU regulatory filings. Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries 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 Effectively communicate the regulatory strategy, risks, mitigations 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 Effective collaboration with to the other line functions within the local affiliate (such as general manager; commercial strategy; market access; pharmacovigilance; quality assurance etc.); proactive regulatory input and support to the local affiliate’s business activities. Fluency in French and English is required. A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive 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, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future 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, 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. 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 modernatx.com/careers 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 and non-discrimination for all employees and qualified applicants without regard to a person's 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. -