# Regulation and Policy Lead, AI for Medicines Safety - £62,905 - £70,817 p.a. + benefits **Company**: Medicines and Healthcare Products Regulatory Agency **Location**: London **Work arrangement**: hybrid **Job type**: Full time **Salary**: GBP 62,905 - 70,817 per year **Category**: Policy & Public Affairs **Industry**: Healthcare **Apply**: https://www.jobsgopublic.com/job/regulation-and-policy-lead-ai-medicines-safety-ps62905-ps70817-pa-benefits-107677?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_47890d08-7d2 ## Description We are currently looking for a Regulation and Policy Lead, AI for Medicines Safety to join our Benefit Risk Evaluation IFunction within the Safety & Surveillance Group. This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. The Safety and Surveillance (S&S) Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agency’s data and evidence generating capabilities, complementing our signal generating abilities. The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical, scientific, clinical and regulatory knowledge, and practical experience. The team conducts benefit-risk evaluations for medicines and medical device across a broad spectrum of therapeutic areas to guide actions that protect patient safety. The team is responsible for: - Signal detection of emerging safety issues - Evaluating the benefit risk of signals and developing effective and measurable risk mitigation measures - Using data and embracing new technologies to develop the evidence to support our actions and understand their impact 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. 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. **Key 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. - 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. - Ensure regulatory activities are delivered in accordance with MHRA governance requirements, quality standards and best practice. **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** **Essential Criteria:** - Experience working in regulatory affairs, regulatory policy, regulatory science or a related discipline within healthcare, life sciences or a related sector - Lead - 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. **Qualifications** - Degree in a relevant scientific, healthcare, policy or regulatory discipline (or equivalent experience). **Behaviours** - Communicating and Influencing - Working Together - Making Effective Decisions **Technical skills** - 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. **Benefits** - Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays - Privilege Leave: 1 day - Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff - Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of six months full pay and six months half pay after five years’ service. - Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service - Civil Service Pension Scheme - Flexible working to ensure staff maintain a healthy work-life balance - Interest free season ticket loan or bike loan - Employee Assistance Services and access to the Civil Service Benevolent Fund - Eligibility to join Motoring , Boundless by CSMA - Variety of staff and Civil Service clubs - On-going learning and development ## Skills ### Required - regulatory affairs - regulatory policy - regulatory science - AI - medicines development - safety assessment - communication - influencing - stakeholder engagement --- Source: [Apply at jobsgopublic.com](https://www.jobsgopublic.com/job/regulation-and-policy-lead-ai-medicines-safety-ps62905-ps70817-pa-benefits-107677?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)