Regulation and Policy Lead, AI for Medicines Safety

Job summary
This is an exciting opportunity to play a lead regulatory and policy role in the delivery of the MHRA's Beyond ADMET: AI for Medicines Safety regulatory sandbox. This unique regulatory science initiative will explore how artificial intelligence can improve the prediction of absorption, distribution, metabolism, excretion and toxicity (ADMET) outcomes and integrate clinical and real-world data to support safer, faster and more efficient medicines development.

Working closely with the Head, AI for Medicines Safety and the Technical Lead, the postholder will provide specialist regulatory and policy expertise across the programme, ensuring that sandbox activities are aligned with current regulatory frameworks and helping to assess the implications of emerging AI-enabled approaches for medicines development and safety assessment.

Main duties of the job
The postholder will support the identification and interpretation of emerging regulatory, scientific and policy developments relating to artificial intelligence, computational methods and non-clinical medicines development. They will work collaboratively with colleagues across the MHRA, government, industry, academia and international regulatory networks to support evidence generation, regulatory learning and policy development arising from the programme.

Initially focused on supporting delivery of the Beyond ADMET: AI for Medicines Safety regulatory sandbox programme, the postholder will also contribute to the MHRA's broader ambitions in AI-enabled regulatory science and innovation, with opportunities to apply their expertise across other priority areas as organisational needs evolve.

The role offers a unique opportunity to contribute to the future development of AI-enabled medicines regulation while helping strengthen the MHRA's position as a global leader in regulatory innovation and patient safety.

About us
The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

Job responsibilities
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.

Person Specification
Qualifications (Essential)

• Degree in a relevant scientific, healthcare, policy or regulatory discipline (or equivalent experience).

Experience (Essential)

• Experience working in regulatory affairs, regulatory policy, regulatory science or a related discipline within healthcare, life sciences or a related sector
• Experience interpreting and applying regulatory frameworks to new technologies, scientific approaches, products or services.
• Experience advising on regulatory or policy issues and translating complex information into practical recommendations.
• Experience contributing to regulatory guidance, policy development, standards development or regulatory science initiatives.
• Experience engaging effectively with stakeholders across government, academia, industry, healthcare organisations or regulatory bodies.
• Experience working collaboratively within multidisciplinary projects, programmes or teams.

Technical Criteria (Essential)

• Understanding of medicines regulation, non-clinical assessment and emerging technologies.
• Knowledge of regulatory policy development processes and regulatory science principles.
• Ability to critically evaluate scientific evidence and assess regulatory implications.
• Understanding of artificial intelligence and machine learning concepts and their application within healthcare and life sciences.
• Awareness of UK and international regulatory approaches relating to AI-enabled technologies.
• Strong written and verbal communication skills, including preparation of briefings, reports and recommendations for senior audiences.

Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details
Employer name: Medicines and Healthcare Products Regulatory Agency
Address: Medicine & Healthcare Regulatory Agency, 10 South Colonnade, London, E14 4PU, United Kingdom
Employer's website: Apply through our website

Contact: Careers, View email address on meeveem.com, View phone number on meeveem.com

Closing date: 09 November 2026
Working pattern: Full-time, Flexible working
Contract: Permanent

Champion the MHRA values and Civil Service behaviours, promoting an ethical, positive and inclusive working environment.