Associate Director, Global Regulatory Science, CMC
Location: London, England (Clinical Development) – Full time – Posted today – Requisition ID R19319
Overview
Moderna offers a unique opportunity to lead regulatory activities and develop CMC strategies for international submissions in the Global Regulatory Science, CMC team. In this role you will guide clinical and regulatory teams, ensuring compliance and preparing high‑quality regulatory documentation that supports the development of cutting‑edge mRNA medicines.
Responsibilities
- Within 3 months: develop and implement effective CMC regulatory strategies for international submissions; review documents for submission‑readiness and ensure conformity with health‑authority guidelines; provide regulatory guidance to manufacturing and quality teams.
- Within 6 months: 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: provide comprehensive CMC regulatory guidance across therapeutic areas; oversee multiple programs, evaluating CMC change controls and their impacts; lead and support all regulatory activities, delivering high‑quality CMC sections of regulatory documentation.
- May require an enhanced pre‑employment check as part of workplace safety commitments.
Basic Qualifications
- BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field (required).
- MS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field (desired).
- 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 therapeutic areas such as vaccines, oncology, and/or rare diseases.
- Strong knowledge of current EU and ROW regulations.
- Strong knowledge of CGMP.
- Extensive experience with CTD format and content regulatory filings.
- Exceptional written and oral communication skills.
Benefits
- Best‑in‑class healthcare and voluntary benefit programs.
- Well‑being resources including fitness, mindfulness, and mental health support.
- Family‑building benefits such as fertility, adoption, and surrogacy support.
- Generous paid time off—including vacation, bank holidays, volunteer days, sabbatical, and global recharge days.
- Savings and investment programs to help plan for the future.
- Location‑specific perks and extras.
Equal Opportunity and Accessibility
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.
