Associate Director, Global Regulatory Science, CMC

Moderna Therapeutics; City of Westminster; On-site; GBP 120,000 - 150,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family building benefits

Generous PTO and sabbatical

Savings and investments

Location-specific perks

Job summary

Moderna, based in London, seeks an experienced Regulatory CMC leader to shape global strategies for mRNA medicines. You will drive regulatory submissions across development programs, interfacing with Manufacturing, Quality, and cross-functional teams to ensure compliance and timely delivery.

You will guide global health authority interactions, optimize submission practices, and leverage digital tools to enhance regulatory excellence and efficiency.

Qualifications

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field required.
• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field desirable
• 10+ years of experience in pharma/biotech manufacturing or analytical
• 8+ years in Biologics-focused Regulatory CMC
• Strong knowledge of EU and ROW regulations and CGMP
• Experience with CTD format and regulatory filings
• Exceptional written and oral communication skills

Responsibilities

• Develop and implement global CMC regulatory strategies for international regulatory submissions.
• Lead and support regulatory CMC activities across product development.
• Prepare, review, and deliver high-quality CMC sections of regulatory submissions.
• Provide expert CMC regulatory guidance to Manufacturing, Quality, and development teams.
• Lead CMC regulatory discussions with global health authorities.
• Drive continuous improvement of regulatory processes for submissions.
• Develop and maintain CMC submission templates for efficient global submissions.
• Provide strategic CMC guidance across multiple therapeutic areas.
• Oversee multiple development programs and assess regulatory impacts of changes.
• Collaborate with cross-functional teams to align regulatory strategies with development plans.

Skills

Regulatory CMC

Cross-functional teamwork

Written and oral communication

Education

BS in Pharmaceutics/Chemistry/Chemical Engineering

MS in Pharmaceutics/Chemistry/Chemical Engineering

Job description

The Role Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. 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.

Support the development, standardization, and maintenance of CMC submission templates to enable efficient and consistent global submissions.

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.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.

Our Mission and Vision

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Equal Opportunity and Diversity

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 values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 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 [e-mail].

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.