Director, Global Regulatory Labeling Strategy

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. Alternatively, the role may be based in Harwell, where Moderna's state-of-the-art facility is shaping the next chapter in mRNA research, development, and manufacturing.Moderna is seeking a Director of Regulatory Labeling Strategy to support our growing pipeline of new programs. Based in the UK (London or Harwell), this role is designed for a future-focused regulatory professional with a sharp, creative mindset, ready to anticipate and overcome the complex challenges involved in rapidly delivering regulatory-compliant labeling for a global portfolio of products. With a geographic remit spanning the United States, European Union, United Kingdom, and Switzerland, the successful candidate will play a pivotal role in shaping global labeling content and strategy across early and late-phase assets.This is an individual contributor role offering deep cross-functional collaboration and exposure to cutting-edge regulatory processes. As part of this role, you will also have opportunities to engage closely with data-driven technologies and explore intersections with Generative AI tools, particularly as they evolve within the regulatory domain. Here's What You'll Be Doing: Your key responsibilities will be: Lead the development of Target Label Profiles (TLPs) for early-phase assets, ensuring strategic alignment with clinical and regulatory goals. Drive the creation and accountability of regulatory labeling content for marketing applications (MAAs) and all related supplements and amendments. Develop high-quality labeling that adheres to regulatory requirements and global standards, serving as the subject matter expert for US, EU, UK, and Swiss markets. Own the regulatory review and content development for product artwork, including trade names, established names, logos, and graphics. Interface with cross-functional project teams to embed labeling considerations early and ensure consistent compliance with the Company Core Data Sheet (CCDS). Your responsibilities will also include: Maintain up-to-date knowledge of evolving global labeling regulations and industry trends; proactively communicate implications to stakeholders. Communicate labeling strategies, risk mitigations, and implementation plans clearly to Project Development Teams, Global Regulatory Science Leadership, and senior stakeholders. Act as a thought leader within the regulatory labeling community, representing Moderna in external forums and maintaining strategic awareness of industry shifts. Provide flexible labeling support across the portfolio, offering coverage for other products during peak workload or team member absences. Contribute to the definition and improvement of the end-to-end global labeling process within the regulatory function. The key Moderna Mindsets you'll need to succeed in the role: We question convention because proven models don't always fuel the future. In this role, you'll be challenged to innovate beyond traditional labeling strategies, especially as you navigate complex, multi-region regulations. You'll be expected to offer bold, data-informed solutions that move faster than standard industry timelines. We digitize everywhere possible using the power of code to maximize our impact on patients. You will be well positioned to explore and implement digital tooling to optimize labeling operations, and may contribute to early-stage exploration of Generative AI in labeling workflows and content generation, contributing to broader automation goals. Here's What You'll Bring to the Table: Experience facilitating meetings and driving consensus and results. Excellent leadership, communication (verbal and written) and collaboration skills. Proven ability in medical/technical writing. Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable. Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations. Integrity: overriding commitment to integrity and high standards for self and others. Results orientation Strategic orientation: ability to link company and departmental visions with daily work Interacts effectively as member of the Regulatory sub-team, communicating effectively on strategies to the Global Labeling Committee and collaborating with business partners, including affiliates and third parties. Flexibility/adaptability: ability to adapt to, and work effectively within, a variety of situations and with various individuals and groups. Relationship building, teamwork and cooperation: builds and maintains strong working relationships with colleagues. Qualifications: BA/BS degree in a scientific discipline required, Master's or PhD preferred. 10+ years of experience in the pharmaceutical industry 7+ years of experience in Regulatory labeling Strong knowledge of artwork development, review and approval required. Strong knowledge of current global regulations, including specifically: e.g. vaccine development regulations and registrations pathways. Strong experience with CTD format and content regulatory filings Exceptional written and oral communication Experience dealing with broad range of stakeholders at all levels internal and external to the company Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.) 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