Associate Director, CMC Regulatory Affairs - International

1d1 day ago

Moderna

London, GB · Full-time · £110,000 – £130,000

About this role

Moderna is seeking an Associate Director, CMC Regulatory Affairs to join its London team. This pivotal role focuses on preparing and overseeing CMC and Quality agency correspondence and regulatory applications, governing CMC submissions for global product development.

The role involves developing and implementing effective CMC regulatory strategies for international submissions such as IND, CTA, BLA, and MAA. You will lead regulatory CMC discussions with health authorities and review documents for submission readiness, ensuring conformity to guidelines.

This position demands a dynamic individual capable of managing multiple projects in a fast-paced, results-oriented environment. You will provide CMC regulatory guidance to manufacturing and quality teams and evaluate change controls across therapeutic areas including vaccines, oncology, and rare diseases.

Moderna's culture emphasizes pursuing options in parallel and acting with urgency to deliver transformative medicines. This role offers the opportunity to shape regulatory strategies for a new generation of mRNA-based therapies in a cutting-edge biotech company.

Requirements

BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field (MS desirable).
10+ years of experience in the pharmaceutical/biotech industry with manufacturing and/or analytical focus.
8+ years of experience in Biologics focused Regulatory CMC.
Multidisciplinary focus on therapeutic areas including 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.

Responsibilities

Developing and implementing effective CMC regulatory strategies for international submissions (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 review and approval.
Developing regulatory processes and procedures to support CMC components of submissions.
Providing CMC regulatory guidance to manufacturing and quality teams and evaluating change controls.
Leading oversight of multiple programs in therapeutic areas including vaccines, oncology, and rare diseases.

Benefits

Best-in-class healthcare with voluntary benefit programs.
Holistic well-being support including fitness, mindfulness, and mental health resources.
Family building benefits covering fertility, adoption, and surrogacy support.
Generous paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.