Regulation and Policy Lead, AI for Medicines Safety

Regulatory and Policy Leadership Lead on all aspects of regulatory and policy advice on AI-enabled approaches in medicines development, safety assessment and related scientific areas. Shape the MHRA's regulatory thinking on emerging AI methodologies and technologies, ensuring outputs from the sandbox inform future regulatory approaches and policy development. Drive horizon scanning and strategic assessment of UK and international regulatory, policy and scientific developments relevant to AI, toxicology, pharmacology, ADMET prediction and medicines development. Lead the interpretation and application of current legislation, regulatory frameworks and guidance relevant to programme activities. Programme Delivery Work closely with the Head, AI for Medicines Safety, Technical Lead and Programme Manager to ensure effective integration of regulatory, scientific and operational considerations across the programme. Provide regulatory and policy leadership on programme planning, delivery and evaluation activities. Develop programme outputs including reports, recommendations, briefings, workshops and publications. Stakeholder Engagement Build effective relationships with stakeholders across the MHRA, government departments, academia, industry, healthcare organisations and international regulatory networks. Represent the programme in regulatory and policy discussions with internal and external stakeholders, communicating regulatory and policy considerations clearly to technical and non-technical audiences. Regulatory Science and Governance Lead on the development of future regulatory frameworks, guidance and policy approaches where appropriate. Identify opportunities to strengthen MHRA capability and leadership in AI-enabled regulation. Ensure regulatory activities are delivered in accordance with MHRA governance requirements, quality standards and best practice. Maintain accurate documentation and evidence to support programme outputs and recommendations. General While the immediate focus of this role is the successful delivery of the

Beyond ADMET

AI for Medicines Safety regulatory sandbox, the postholder will be expected to contribute regulatory and policy expertise across the Agency's evolving AI and regulatory science agenda. Champion the MHRA values and Civil Service behaviours, promoting an ethical, positive and inclusive working environment.