Associate Director, CMC Regulatory Affairs, International

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:

• Develop and implement effective CMC regulatory strategies for international submissions (e.g., IND/CTA/BLA/MAA) and identify regulatory risks.
• Provide guidance on regulatory CMC aspects of product development projects.
• Review documents for submission readiness, ensuring conformity to health authority guidelines.
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate the review and approval of submissions.
• Develop regulatory processes and procedures to support the CMC components of regulatory submissions.

Your Responsibilities Will Also Include:

• Support the creation and maintenance of CMC submission templates.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
• Offer interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs.
• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).

The key Moderna Mindsets you’ll need to succeed in the role:

• Pursue options in parallel: A strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies.
• Act with urgency: In a fast-paced and result-oriented environment, 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 a closely related field is required.
• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is desirable.
• 10+ years of experience in the pharmaceutical/biotech industry with a 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 skills.

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.

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. Moderna is a smoke-free, alcohol-free, and drug-free work environment. 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 for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.