Associate Director, Global Regulatory Science, Cmc

Moderna; England; On-site; GBP 120,000 - 150,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family building benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking an experienced Associate Director for Global Regulatory Science, CMC, to lead regulatory activities and develop CMC strategies for international submissions. You will guide product development projects and oversee critical regulatory documentation to enable transforms in patient care.

The role requires extensive experience in regulatory CMC, especially for biologics, and strong cross-functional collaboration with manufacturing and QA teams.

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 in 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.
• Enhanced pre-employment checks may be required.

Responsibilities

• Develop and implement effective CMC regulatory strategies for international submissions.
• Review documents for submission-readiness per health authority guidelines.
• Provide regulatory guidance to manufacturing and quality teams.
• Lead regulatory CMC discussions with health authorities.
• Enhance regulatory processes supporting CMC components.
• Support creation and maintenance of CMC submission templates.
• Provide regulatory guidance for various therapeutic areas.
• Oversee multiple programs and assess CMC change controls.
• Lead and support all regulatory activities delivering high-quality CMC documentation.

Skills

Regulatory strategy

Regulatory CMC

EU & ROW regulations

CGMP knowledge

CTD filings

Regulatory communications

Pre-employment checks

Education

BS in Pharmaceutics/Chemistry/Engineering

MS in Pharmaceutics/Chemistry/Engineering (desirable)

Tools

Job description

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is seeking an experienced Associate Director for Global Regulatory Science, CMC. This pivotal role involves leading regulatory activities, developing CMC strategies for international submissions, ensuring compliance, and guiding product development projects. You will be at the forefront of preparing and overseeing critical regulatory documentation, directly contributing to the development of transformative medicines for patients.

Here’s What You’ll Do

• Within 3 Months, You Will…
  Develop and implement effective CMC regulatory strategies for international submissions.
  Start reviewing documents for submission-readiness, ensuring conformity with health authority guidelines.
  Begin providing regulatory guidance to manufacturing and quality teams.
• Within 6 Months, You Will…
  Lead regulatory CMC discussions and interactions with health authorities.
  Enhance regulatory processes and procedures supporting CMC components.
  Support the creation and maintenance of CMC submission templates.
• Within 12 Months, You Will…
  Provide comprehensive CMC regulatory guidance for various therapeutic areas.
  Oversee multiple programs, evaluating CMC change controls and their impact on internal programs.
  Lead and support all regulatory activities, delivering high-quality CMC sections of regulatory documentation.

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 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 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, 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.

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.