Associate Director, CMC Regulatory Science, International

Moderna Therapeutics; Greater London; On-site; GBP 110,000 - 150,000; Full time

Benefits offered by this job

Best-in-class healthcare

Family building benefits

Generous paid time off

Job summary

Moderna Therapeutics is seeking an Associate Director, CMC Regulatory Science-International based at the UK site. You will develop regulatory strategies, oversee submissions, and guide cross-functional teams on CMC matters for global programs, including vaccines and oncology.

The role requires leading interactions with regulatory authorities and managing multiple projects in a fast-paced environment. You will bring 10+ years in pharma/biotech with biologics CMC experience, and an MS/PhD in a

Qualifications

• 10+ years of experience in the pharmaceutical/biotech industry with regulatory CMC focus.
• 8+ years of biologics-focused regulatory CMC experience.
• Strong knowledge of EU and ROW regulations and CTD format.

Responsibilities

• Develop/implement effective CMC regulatory strategies for global submissions (IND/CTA/MAA/BLAs).
• Provide guidance for regulatory CMC aspects of product development projects.
• Review documents for submission-readiness to ensure adherence to guidelines.
• Drive regulatory CMC discussions with health authorities to facilitate approvals.
• Lead oversight of multiple programs across vaccines, oncology and/or rare diseases.

Skills

CMC regulatory strategy

Regulatory submissions

Cross-functional leadership

Regulatory compliance

Project management

Education

MS/PhD in Molecular Biology or related field

Job description

## Associate Director, CMC Regulatory Science, InternationalApplylocations: London - England: Clinical Developmenttime type: Full timeposted on: Posted Todayjob requisition id: R19226**The Role:**The Associate Director, CMC Regulatory Science-International will be based at the Harwell, UK site and as part of a team be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of mRNA products. This position will contribute to and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio will be a key success component.**Here’s What You’ll Do:*** Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks* Provide guidance for regulatory CMC aspects of product development projects* Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines* Drive Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions* Support the development of regulatory processes and procedures to support CMC components of regulatory submissions* Support the creation and maintenance of CMC submission templates* Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls* Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs* Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)**Here’s What You’ll Need (Basic Qualifications)*** MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.* 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus* 8+ years of experience in Biologics focused Regulatory CMC* As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check**Here’s What You’ll Bring to the Table (Preferred Qualifications)*** 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* A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.**Pay & Benefits****At 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 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 extrasThe 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, 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 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].