Associate Director, Global Regulatory Science, CMC in London

Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you will work alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna’s commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients’ lives worldwide. We invite professionals to join us in Basel, contributing to our mission of delivering groundbreaking mRNA medicines and impacting lives worldwide.

This pivotal role involves leading regulatory activities, developing CMC strategies for international submissions, ensuring compliance, and guiding product development projects. You will be at the forefront of preparing and overseeing critical regulatory documentation, directly contributing to the development of transformative medicines for patients.

Here’s What You’ll Do

• Within 3 Months, You Will:
• Develop and implement effective CMC regulatory strategies for international submissions.
• Start reviewing documents for submission-readiness, ensuring conformity with health authority guidelines.
• Begin providing regulatory guidance to manufacturing and quality teams.
• Within 6 Months, You Will:
• Lead regulatory CMC discussions and interactions with health authorities.
• Enhance regulatory processes and procedures supporting CMC components.
• Support the creation and maintenance of CMC submission templates.
• Within 12 Months, You Will:
• Provide comprehensive CMC regulatory guidance for various therapeutic areas.
• Oversee multiple programs, evaluating CMC change controls and their impact on internal programs.
• Lead and support all regulatory activities, delivering high-quality CMC sections of regulatory documentation.

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 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.

As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.

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.

Equal Opportunity Statement

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. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 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.