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 London, a global center of science and innovation. Our team drives commercial operations to bring our mRNA medicines to patients across the UK. We welcome talent ready to help transform global health. This is an opportunity for an experienced CMC Regulatory Affairs professional to play a critical role in advancing Moderna’s global product portfolio. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products. The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation. This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients. Here’s What You’ll Do Develop and implement effective global CMC regulatory strategies for international submissions, including INDs, CTAs, BLAs, MAAs, and other regional regulatory applications. Lead the preparation, review, and oversight of CMC and Quality-related agency correspondence and regulatory submissions. Govern and coordinate CMC submission activities to ensure alignment with global regulatory requirements and business objectives. Identify, assess, and proactively mitigate regulatory risks impacting product development, lifecycle management, and market access activities. Provide strategic CMC regulatory guidance to cross-functional product development teams throughout the product lifecycle. Review regulatory documentation for submission readiness, ensuring compliance with applicable health authority requirements, regulations, and guidance. Lead CMC regulatory discussions, negotiations, and interactions with international health authorities to facilitate efficient review and approval of submissions. Develop, implement, and continuously improve regulatory processes and procedures supporting CMC components of global regulatory filings. Support the creation, maintenance, and optimization of CMC submission templates and associated regulatory documentation standards. Partner closely with Manufacturing, Technical Operations, Quality, and Development teams to provide regulatory guidance on CMC-related matters. Evaluate CMC change controls and provide regulatory assessments to support implementation strategies and compliance requirements. Interpret evolving regulatory guidance documents, regulations, directives, and policy changes, advising internal stakeholders on their applicability and impact. Provide regulatory compliance support across global development and commercial programs. Lead regulatory oversight of multiple programs spanning vaccines, oncology, and rare disease therapeutic areas. Support lifecycle management activities for approved and post-approval biologic products across international markets. Contribute to regulatory planning and execution across emerging markets, with particular emphasis on LATAM regulatory environments. Leverage digital technologies and emerging AI-enabled capabilities to enhance regulatory intelligence, submission planning, data management, and operational efficiency. Operate effectively in a fast-paced, highly collaborative environment while managing multiple complex projects and competing priorities. The key Moderna Mindsets you’ll need to succeed in the role Pursue options in parallel: This role requires a strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies. Act with urgency: Given the fast-paced and result-oriented environment, acting swiftly and decisively is crucial to meet deadlines and deliver transformative medicines to patients. Here’s What You’ll Need (Basic Qualifications) BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required. MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus 8+ years of experience in Biologics focused Regulatory CMC Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases) Strong knowledge of current EU and ROW regulations Strong knowledge of Cgmp Strong experience with CTD format and content regulatory filings Exceptional written and oral communication Pay & Benefits 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. Best-in-class 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. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home