Associate Director, CMC Regulatory Affairs, International

The Role

Moderna is looking for an Associate Director, CMC Regulatory Affairs-International, to join our team based in London, UK.

This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products. The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation. This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients.

Here's What You'll Do

• Developing and implementing effective CMC regulatory strategies for international submissions (e.g., IND/CTA/BLA/MAA) and identifying regulatory risks.
• Providing guidance on regulatory CMC aspects of product development projects.
• Reviewing documents for submission readiness, ensuring conformity to health authority guidelines.
• Leading Regulatory CMC discussions and interactions with health authorities to facilitate the review and approval of submissions.
• Developing regulatory processes and procedures to support the CMC components of regulatory submissions.
• Supporting the creation and maintenance of CMC submission templates.
• Providing CMC regulatory guidance to manufacturing and quality teams; evaluating CMC change controls.
• Offering interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs.
• Leading oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).

Mindsets and Approach

• Pursue options in parallel - explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies.
• Act with urgency - act swiftly and decisively to meet deadlines and deliver transformative medicines to patients.

Here's What You'll Need (Basic Qualifications)

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable.
• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
• 8+ years of experience in biologics-focused regulatory CMC.
• 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.

Pay & Benefits

• Best-in-class healthcare plus voluntary benefit programs to support your unique needs.
• 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.

Equal Opportunity Employment Statement

Moderna is committed to equal opportunity in employment and non discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position should contact the Accommodations and Adjustments team at .