Director, Regulatory Science - France

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 innovativ