Associate Director, CMC Regulatory Science, International

About the Role Based at the Harwell, UK site, the Associate Director, CMC Regulatory Science-International will oversee CMC and Quality-related agency correspondence and regulatory applications, and govern CMC submissions and regulatory compliance support for mRNA product development. The role contributes to regulatory activities to deliver high-quality CMC sections of regulatory documentation and requires managing multiple projects in a fast-moving environment. Developing regulatory strategies for the products in Moderna’s portfolio will be a key success component. What You'll Do

• Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance for regulatory CMC aspects of product development projects
• Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
• Drive Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
• Support the development of regulatory processes and procedures to support CMC components of regulatory submissions
• Support the creation and maintenance of CMC submission templates
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls
• Provide interpretation of regulatory guidance documents, regulations and directives – advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) What We're Looking For
• MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required
• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
• 8+ years of experience in Biologics focused Regulatory CMC
• As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check
• 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
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and committed to excellence Nice to Have
• Additional therapeutic area breadth or leadership experience across multiple programs and pipelines
• Prior regulatory leadership roles involving international submissions and agency interactions Compensation & Benefits
• Salary not disclosed; benefits and perks not specified in the posting