Associate Director, CMC Regulatory Science - UK

Moderna; Greater London; Hybrid; GBP 120,000 - 150,000; Full time

Job summary

Moderna in London invites applications for a senior Regulatory CMC leadership role focused on UK-manufactured and UK-licensed mRNA products. You will shape regulatory strategies, lead submissions and guide lifecycle management across development, registration, and post-approval activities in partnership with Technical Development, Manufacturing, Quality, Clinical, Commercial and Regulatory teams.

You will translate evolving UK CMC requirements into actionable plans, monitor MHRA guidance, and

Job description

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 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. Shape regulatory approaches that support development, product registration, commercialisation and post-approval activities, ensuring alignment with Moderna's 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 Moderna's 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: P