Associate Director, CMC Regulatory Science, International

The Role:

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 focus8+ years of experience in Biologics focused Regulatory CMCAs 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 cGMPStrong experience with CTD format and content regulatory filings

Exceptional written and oral communicationA 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 needsA 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.

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…