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
As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check
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
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.
Associate Director, CMC Regulatory Science, International • London, England
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