Associate Director, CMC Regulatory Science - UK

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 Moderna’s 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 Moderna’s 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.

Here’s What You’ll 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.
• 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.
• 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.
• 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).
• Translate evolving regulatory expectations into actionable strategies: Monitor, interpret and communicate developments in UK CMC regulations, MHRA guidance, regulatory policy and applicable international requirements.
• 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.
• 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.
• Shape global CMC regulatory approaches: Contribute to the development and execution of international CMC regulatory strategies for assigned programmes.
• Champion regulatory process excellence and innovation: Lead the development and continuous improvement of regulatory processes, procedures and working practices associated with CMC submissions.
• 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.
• 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.
• Lead complex regulatory decisions with confidence and judgement: Navigate technically challenging regulatory situations involving competing priorities, incomplete information or evolving health authority expectations.
• Mentor colleagues and strengthen regulatory science capabilities: Provide technical leadership, coaching and mentorship to junior regulatory professionals.
• Build strong partnerships across the organisation: Establish trusted relationships with technical experts, programme leaders and senior stakeholders across Moderna’s global organisation.
• Contribute to Moderna’s continued growth and transformation: Bring a bold, relentless, curious and collaborative approach to regulatory leadership.

Here’s What You’ll Need (Basic Qualifications)

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
• 8+ years of experience in the pharmaceutical/biotech industry, 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).

Here’s What You’ll 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 Moderna’s 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.

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.

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.