Associate Director, Global Regulatory Science, CMC

ModernaMultiple locationsonsiteSalary not postedView the original posting at Moderna ↗

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 exciting opportunity for an experienced regulatory professional to shape the global CMC regulatory strategy for an innovative portfolio of mRNA medicines. Working across multiple development programs, you will play a critical role in driving international regulatory submissions, influencing product development, and ensuring the highest standards of regulatory compliance. As an individual contributor with global reach, you will collaborate with multidisciplinary teams and health authorities while helping accelerate the delivery of transformative medicines to patients worldwide. You will also have opportunities to work alongside teams leveraging advanced digital capabilities and Generative AI tools to enhance regulatory excellence and operational efficiency. Here’s What You’ll Do Develop and implement global CMC regulatory strategies to support international regulatory submissions across Moderna's mRNA development portfolio. Lead and support regulatory CMC activities throughout product development, ensuring successful execution of global regulatory objectives. Prepare, review, and deliver high-quality CMC sections of regulatory submissions, ensuring they are submission-ready and compliant with global health authority requirements. Provide expert CMC regulatory guidance to Manufacturing, Quality, and cross-functional development teams throughout the product lifecycle. Lead CMC regulatory discussions and represent Regulatory Affairs in interactions with global health authorities. Drive continuous improvement of regulatory processes and procedures that support CMC regulatory activities and submission excellence. Support the development, standardization, and maintenance of CMC submission templates to enable efficient and consistent global submissions. Provide strategic CMC regulatory guidance across multiple therapeutic areas, supporting innovative product development programs. Oversee multiple global development programs simultaneously, evaluating CMC change controls and assessing their potential regulatory impact. Partner closely with cross-functional teams to ensure regulatory strategies align with development objectives, compliance requirements, and global registration plans. Contribute to the advancement of Moderna's transformative mRNA medicines by delivering robust regulatory strategies that accelerate access for patients worldwide. Collaborate with teams adopting advanced digital capabilities and Generative AI tools to enhance regulatory processes, document quality, and operational efficiency. The key Moderna Mindsets you'll need to succeed in the role: "We obsess over learning. We don’t have to be the smartest we have to learn the fastest." "We act with dynamic range, driving strategy and execution at the same time at every step." 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 As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-

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