Associate Director, CMC Regulatory Affairs-International (London, UK)
Modena is looking for an Associate Director, CMC Regulatory Affairs-International to join a team in London, UK. The role focuses on preparing and overseeing CMC and quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for global product development. The successful candidate will lead and support all regulatory activities, ensuring high‑quality CMC sections of regulatory documentation while managing multiple projects in a fast‑paced environment.
Key Responsibilities
* 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 review and approval of submissions.
* Develop regulatory processes and procedures to support the CMC components of regulatory submissions.
* 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 applicability and impact on internal programs.
* Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).
Qualifications
* BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
* MS in the same field is 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 peripheral 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.
Benefits
* Best‑in‑class healthcare and voluntary benefit programs.
* Holistic well‑being support, including fitness, mindfulness, and mental health resources.
* Family‑building benefits: fertility, adoption, and surrogacy support.
* Generous paid time off: vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown.
* Savings and investments plans for future planning.
* Location‑specific perks and extras.
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.
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