Associate Director, CMC Regulatory Science, International in Lincolnshire

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.

Here’s 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
• 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)

Here’s What You’ll Need (Basic Qualifications):

• 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

Here’s What You’ll Bring to the Table (Preferred Qualifications):

• 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.

Pay & 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

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.

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.