Associate Director, CMC Regulatory Science - UK

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: 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 jun