Associate Director, CMC Regulatory Science, International

The Associate Director, CMC Regulatory Science-International will be based at the Harwell, UK site and as part of a team be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of mRNA products. This position will contribute to and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio will be a key success component.

Responsibilities

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; Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls; Provides interpretation of regulatory guidance documents, regulations and directives – advises 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)

Requirements

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

Nice to have

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 Collaborative.

Benefits

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