Associate Director, CMC Regulatory Affairs, International

The RoleModerna is looking for a 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 Developing and implementing effective CMC regulatory strategies for international submissions (e.g., 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 the review and approval of submissions.Developing regulatory processes and procedures to support the CMC components of regulatory submissions.Your responsibilities will also includeSupporting the creation and maintenance of CMC submission templates.Providing CMC regulatory guidance to manufacturing and quality teams; evaluating CMC change controls.Offering interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs.Leading 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 rolePursue options in parallel: This role requires a strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies.Act with urgency: Given the fast-paced and result-oriented environment, acting swiftly and decisively is crucial to meet deadlines and deliver transformative medicines to patients.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 desirable10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus8+ years of experience in Biologics focused Regulatory CMCMultidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)Strong knowledge of current EU and ROW regulationsStrong knowledge of CgmpStrong experience with CTD format and content regulatory filingsExceptional written and oral communicationPay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Best-in-class healthcare, plus voluntary benefit programs to support your unique needsA holistic approach to well-being with access to fitness, mindfulness, and mental health supportFamily building benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 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