This lead role sits within the MHRA's AI for Medicines Safety programme, supporting the Beyond ADMET regulatory sandbox, which tests how artificial intelligence can predict medicine absorption, toxicity and related outcomes. The postholder supplies regulatory and policy expertise, keeping sandbox work aligned with current frameworks and assessing what AI-enabled approaches mean for medicines development and safety. The work spans government, industry, academia and international regulators, with scope to extend to other AI and regulatory science priorities over time.
What the job involves
- Lead regulatory and policy advice on AI-enabled approaches in medicines development and safety assessment
- Shape MHRA regulatory thinking on AI methodologies so sandbox outputs inform future approaches and policy
- Lead horizon scanning and strategic assessment of UK and international regulatory, policy and scientific developments
- Lead the interpretation and application of legislation, frameworks and guidance for programme activities
- Provide regulatory and policy leadership on programme planning, delivery and evaluation
- Develop programme outputs including reports, recommendations, briefings, workshops and publications
- Build relationships with stakeholders across the MHRA, government, academia, industry, healthcare and international networks
- Represent the programme in regulatory and policy discussions, communicating clearly to technical and non-technical audiences
- Lead development of future regulatory frameworks, guidance and policy approaches
- Ensure regulatory activities meet MHRA governance, quality standards and best practice, maintaining documentation and evidence
- Contribute regulatory and policy expertise across the Agency's wider AI and regulatory science agenda
- Champion MHRA values and Civil Service behaviours
Qualifications
- Degree in a relevant scientific, healthcare, policy or regulatory discipline, or equivalent experience
Experience
- Regulatory affairs, regulatory policy, regulatory science or related experience in healthcare, life sciences or a related sector
- Interpreting and applying regulatory frameworks to new technologies, scientific approaches, products or services
- Advising on regulatory or policy issues and translating complex information into practical recommendations
- Contributing to regulatory guidance, policy development, standards or regulatory science initiatives
- Engaging stakeholders across government, academia, industry, healthcare organisations or regulatory bodies
- Working collaboratively within multidisciplinary projects, programmes or teams
Skills & knowledge
- Understanding of medicines regulation, non-clinical assessment and emerging technologies
- Knowledge of regulatory policy development processes and regulatory science principles
- Critically evaluating scientific evidence and assessing regulatory implications
- Understanding of AI and machine learning concepts and their application in healthcare and life sciences
- Awareness of UK and international regulatory approaches to AI-enabled technologies
- Strong written and verbal communication, including briefings, reports and recommendations for senior audiences
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Contact Details:
The Methodist Church in Britain Recruitment Team
