Regulation & Policy Lead, AI for Medicines Safety

The Medicines And Healthcare Products Regulatory Agency; Greater London; Presencial; GBP 65 000 - 90 000; Tempo integral

Resumo da oferta

The Medicines And Healthcare Products Regulatory Agency (MHRA) seeks an experienced Regulation & Policy Lead for AI in Medicines Safety. You will join the Benefit/Risk Evaluation Team I within the Safety and Surveillance group in the UK.

You will lead regulatory and policy work for the Beyond ADMET: AI for Medicines Safety sandbox, aligning activities with current frameworks and collaborating with government, industry, academia, and international regulators to drive evidence generation and

Qualificações

• Understanding medicines regulation and regulatory science principles.
• Knowledge of regulatory policy development processes.
• Ability to evaluate scientific evidence and assess regulatory implications.
• Understanding of artificial intelligence and machine learning concepts in healthcare.
• Awareness of UK and international regulatory approaches relating to AI-enabled technologies.
• Strong written and verbal communication skills for senior audiences.

Responsabilidades

• Lead regulatory and policy work for the AI for Medicines Safety sandbox.
• Collaborate with MHRA, government, industry, academia and international networks.
• Identify regulatory and policy developments in AI-enabled medicines development.
• Assess implications of innovative AI approaches for safety assessment.

Conhecimentos

Regulatory policy leadership

AI/ML concepts in healthcare

Medicines regulation knowledge

Regulatory science principles

Stakeholder engagement

Regulatory policy development

Evidence appraisal and interpretation

Written and verbal communication

Formação académica

Degree in a relevant scientific/healthcare/regulatory discipline

Descrição da oferta de emprego

The MHRA is transforming. Through enabling innovation, making the right judgements of the benefits and risks of medical products and forging the right partnerships in the UK and internationally, it aims to deliver world class regulation and improved outcomes for UK patients.

We are currently looking for experienced Regulation & Policy Lead, AI for Medicines Safety to join our Benefit/Risk Evaluation Team I in the Safety and Surveillance group.

Within a week of working here, your day could look like this: Responsible for playing 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.

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.

The successful candidate will have a degree in a relevant scientific, healthcare, policy or regulatory discipline (or equivalent experience).

• 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.

Our successful candidate will have:

• 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

Closing date: 09 November 2026