Quality and Risk - Associate Director in London

The Role

Joining Moderna means advancing mRNA science to transform medicine. Moderna is strengthening its presence in London, a global center of science and innovation. Our team drives commercial operations to bring our mRNA medicines to patients across the UK. We welcome talent ready to help transform global health.

This is an exciting opportunity for an experienced regulatory professional to shape the global CMC regulatory strategy for an innovative portfolio of mRNA medicines. Working across multiple development programs, you will play a critical role in driving international regulatory submissions, influencing product development, and ensuring the highest standards of regulatory compliance. As an individual contributor with global reach, you will collaborate with multidisciplinary teams and health authorities while helping accelerate the delivery of transformative medicines to patients worldwide. You will also have opportunities to work alongside teams leveraging advanced digital capabilities and Generative AI tools to enhance regulatory excellence and operational efficiency.

Here's What You'll Do

• Develop and implement global CMC regulatory strategies to support international regulatory submissions across Moderna's mRNA development portfolio.
• Lead and support regulatory CMC activities throughout product development, ensuring successful execution of global regulatory objectives.
• Prepare, review, and deliver high-quality CMC sections of regulatory submissions, ensuring they are submission-ready and compliant with global health authority requirements.
• Provide expert CMC regulatory guidance to Manufacturing, Quality, and cross-functional development teams throughout the product lifecycle.
• Lead CMC regulatory discussions and represent Regulatory Affairs in interactions with global health authorities.
• Drive continuous improvement of regulatory processes and procedures that support CMC regulatory activities and submission excellence.
• Provide strategic CMC regulatory guidance across multiple therapeutic areas, supporting innovative product development programs.
• Oversee multiple global development programs simultaneously, evaluating CMC change controls and assessing their potential regulatory impact.
• Partner closely with cross-functional teams to ensure regulatory strategies align with development objectives, compliance requirements, and global registration plans.
• Contribute to the advancement of Moderna's transformative mRNA medicines by delivering robust regulatory strategies that accelerate access for patients worldwide.
• Collaborate with teams adopting advanced digital capabilities and Generative AI tools to enhance regulatory processes, document quality, and operational efficiency.

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 certain 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.

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

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive 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.

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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 UK.

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.

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.

Clinical Development Type: Full time