Associate Director, CMC Regulatory Affairs, International

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 opportunity for an experienced CMC Regulatory Affairs professional to play a critical role in advancing Modernas global product portfolio. 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.

Heres What Youll Do

• Develop and implement effective global CMC regulatory strategies for international submissions including INDs CTAs BLAs MAAs and other regional regulatory applications.
• Lead the preparation review and oversight of CMC and Quality-related agency correspondence and regulatory submissions.
• Govern and coordinate CMC submission activities to ensure alignment with global regulatory requirements and business objectives.
• Identify assess and proactively mitigate regulatory risks impacting product development lifecycle management and market access activities.
• Provide strategic CMC regulatory guidance to cross-functional product development teams throughout the product lifecycle.
• Review regulatory documentation for submission readiness ensuring compliance with applicable health authority requirements regulations and guidance.
• Lead CMC regulatory discussions negotiations and interactions with international health authorities to facilitate efficient review and approval of submissions.
• Develop implement and continuously improve regulatory processes and procedures supporting CMC components of global regulatory filings.
• Support the creation maintenance and optimization of CMC submission templates and associated regulatory documentation standards.
• Partner closely with Manufacturing Technical Operations Quality and Development teams to provide regulatory guidance on CMC-related matters.
• Evaluate CMC change controls and provide regulatory assessments to support implementation strategies and compliance requirements.
• Interpret evolving regulatory guidance documents regulations directives and policy changes advising internal stakeholders on their applicability and impact.
• Provide regulatory compliance support across global development and commercial programs.
• Lead regulatory oversight of multiple programs spanning vaccines oncology and rare disease therapeutic areas.
• Support lifecycle management activities for approved and post-approval biologic products across international markets.
• Contribute to regulatory planning and execution across emerging markets with particular emphasis on LATAM regulatory environments.
• Leverage digital technologies and emerging AI-enabled capabilities to enhance regulatory intelligence submission planning data management and operational efficiency.
• Operate effectively in a fast-paced highly collaborative environment while managing multiple complex projects and competing priorities.

The key Moderna Mindsets youll need to succeed in the role

• Pursue 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.

Heres What Youll 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

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat 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

• Savingsandinvestments 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 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 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 persons 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.

Were 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 .

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