Associate Director, CMC Regulatory Science UK

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.

As a strategic leader within Modernas Global Regulatory CMC organisation you will shape and drive Chemistry Manufacturing and Controls (CMC) regulatory strategies for UK-manufactured and UK-licensed mRNA products from development through commercialisation and post-approval lifecycle management. Reporting to the Senior Director Global Regulatory CMC you will combine deep regulatory science expertise with strategic judgement to navigate complex MHRA requirements secure timely regulatory approvals and influence global regulatory decisions. Working across Technical Development Manufacturing Quality Clinical Commercial and Regulatory teams you will provide scientific and regulatory leadership establish robust CMC compliance frameworks and help advance transformative mRNA medicines to patients.

This position can be based at Modernas central London office in Victoria or at our manufacturing site in Harwell Oxfordshire. If based in London regular travel to Harwell will be expected. While your primary regulatory responsibility will focus on the UK you will also contribute to international submissions global regulatory strategies and cross-market lifecycle management activities.

Heres What Youll Do:

• Define and lead CMC regulatory strategy for our mRNA portfolio: Take accountability for developing executing and continuously refining comprehensive CMC regulatory strategies for assigned UK-manufactured and UK-licensed products across all stages of the product lifecycle. Shape regulatory approaches that support development product registration commercialisation and post-approval activities ensuring alignment with Modernas business priorities evolving scientific requirements and country-specific regulatory expectations in the UK and international markets.
• Drive strategically robust CMC regulatory submissions: Provide regulatory leadership and oversight for the preparation scientific positioning and management of CMC and Quality-related regulatory submissions. Ensure submissions are scientifically robust strategically aligned technically accurate and submission-ready with particular emphasis on applicable MHRA requirements and Common Technical Document (CTD) expectations. Partner with technical and regulatory colleagues to establish clear submission strategies that enable efficient reviews timely approvals and successful product lifecycle transitions.
• Lead regulatory assessment of manufacturing and quality changes: Provide expert regulatory evaluations of proposed manufacturing process changes analytical changes and other quality-related modifications affecting development and commercial products. Determine potential regulatory filing implications assess risks and mitigation options and recommend appropriate regulatory pathways in alignment with product lifecycle management strategies applicable legislation and market-specific requirements.
• Serve as a trusted regulatory CMC expert in MHRA interactions: Act as a primary point of contact for CMC-related regulatory matters with the Medicines and Healthcare products Regulatory Agency (MHRA) and engage with other relevant international health authorities. Lead or participate in high-level regulatory meetings scientific discussions and agency interactions articulating complex CMC strategies responding to regulatory questions and helping facilitate efficient reviews and approvals that support development milestones and global product launches.
• Translate evolving regulatory expectations into actionable strategies: Monitor interpret and communicate developments in UK CMC regulations MHRA guidance regulatory policy and applicable international requirements. Assess their scientific technical and operational implications translating evolving expectations into programme-level regulatory strategies internal standards submission approaches and functional best practices that strengthen Modernas regulatory readiness.
• Provide strategic oversight of CMC compliance and regulatory risk: Establish and strengthen regulatory compliance frameworks that support the development manufacture and commercialisation of mRNA medicines. Anticipate complex regulatory challenges identify potential compliance gaps and proactively develop risk mitigation strategies. Apply sound scientific and regulatory judgement to complex or ambiguous situations balancing regulatory expectations development priorities commercial objectives and long-term lifecycle considerations.
• Lead cross-functional regulatory strategy and decision-making: Provide strategic direction across matrix teams involving Technical Development Process Development Manufacturing Quality Clinical Commercial and Regulatory stakeholders. Build alignment around regulatory objectives submission priorities and critical programme milestones influencing senior stakeholders without relying on direct reporting authority. Facilitate effective cross-functional decision-making and ensure timely coordinated responses to regulatory questions and emerging compliance challenges.
• Shape global CMC regulatory approaches: Contribute to the development and execution of international CMC regulatory strategies for assigned programmes ensuring that UK regulatory considerations are integrated with broader global development and commercialisation plans. Navigate differences between national regulatory requirements evaluate potential implications for international submissions and help maintain adaptable regulatory strategies across complex development and post-approval programmes.
• Champion regulatory process excellence and innovation: Lead the development and continuous improvement of regulatory processes procedures and working practices associated with CMC submissions. Develop scalable submission templates standardised frameworks and effective regulatory approaches that improve consistency technical quality and operational efficiency across the Regulatory CMC organisation.
• Explore digital innovation and emerging regulatory technologies: Identify opportunities to enhance regulatory intelligence submission planning technical knowledge management and CMC documentation through approved digital solutions including Generative AI tools where appropriate. Explore how emerging technologies could support regulatory information synthesis interpretation of evolving guidance structured document preparation and process efficiency while maintaining appropriate scientific oversight data integrity confidentiality and regulatory compliance.
• Represent CMC regulatory strategy in governance and leadership discussions: Present complex regulatory issues scientific considerations risks options and recommendations to senior stakeholders and internal governance forums. Clearly communicate the rationale behind proposed regulatory approaches explain potential trade-offs and influence strategic decisions that support product development regulatory compliance and business objectives.
• Lead complex regulatory decisions with confidence and judgement: Navigate technically challenging regulatory situations involving competing priorities incomplete information or evolving health authority expectations. Evaluate available options develop risk-based recommendations and drive decisions that protect regulatory compliance while enabling timely programme progression and maintaining alignment with global regulatory strategies.
• Mentor colleagues and strengthen regulatory science capabilities: Provide technical leadership coaching and mentorship to junior regulatory professionals sharing expertise in biologics CMC regulatory submissions agency interactions and lifecycle management. Foster an environment of continuous learning scientific curiosity and regulatory innovation helping colleagues develop the judgement and capabilities required to navigate increasingly complex regulatory challenges.
• Build strong partnerships across the organisation: Establish trusted relationships with technical experts programme leaders and senior stakeholders across Modernas global organisation. Promote collaborative problem-solving maintain clear and proactive communication and help align regulatory science with manufacturing capabilities quality expectations clinical development priorities and commercial objectives.
• Contribute to Modernas continued growth and transformation: Bring a bold relentless curious and collaborative approach to regulatory leadership embracing opportunities to improve established practices strengthen regulatory capabilities and support the development and commercialisation of innovative mRNA medicines.

The key Moderna Mindsets youll need to succeed in the role:

• We act with dynamic range driving strategy and execution at the same time at every step.
• We question convention because proven models dont always fuel the future.

Heres What Youll Need (Basic Qualifications)

• BS/MS/PhD in Molecular Biology Pharmaceutics Chemistry Chemical Engineering or closely related field is required.
• 8 years of experience in thepharmaceutical/biotechindustry manufacturing and/or analytical focus
• 5 years of experience in Biologics focused Regulatory CMC
• Strong knowledge of current UK CMC regulations including CTD format and content of CMC regulatory submissions
• Knowledge of current CMC regulations outside of the UK as well is preferred
• Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development product registration and post-approval lifecycle management (LCM)

Heres What Youll Bring to the Table (Preferred Qualifications)

• Ability to lead and influence in a dynamic cross-functional matrix environment to drive strategic alignment and achieve critical regulatory milestones
• Ability to work independently exercise sound judgment and make risk-based regulatory recommendations in complex or ambiguous situations
• Exceptional written and oral communication including the ability to clearly frame regulatory risks options recommendations and trade-offs for senior stakeholders
• Demonstrated ability to define and lead global CMC regulatory strategy for complex development or lifecycle programs
• Ability to lead without direct authority and drive alignment across Technical Development Manufacturing Quality Clinical Commercial and Regulatory stakeholders
• Experience contributing to CMC regulatory policy interpretation process improvement submission standards or functional best practices
• Demonstrated ability to represent CMC regulatory strategy in internal governance forums and as appropriate in interactions with health authorities
• A desire to make an impact as part of a high-growth transformational company that is Bold Relentless Curious and Collaborative.

As part of Modernas commitment to workplace safety this role may require an enhanced pre-employment check.

Our Working Model

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.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Pay & Benefits

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

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 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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