Description
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.
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.
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.
- 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.
Person Specification:
- Qualifications:
- Degree in a relevant scientific, healthcare, policy or regulatory discipline (or equivalent experience).
- Experience:
- 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:
- 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.