Associate Director, CMC Regulatory Affairs, International

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 ou