Head Of Regulatory Policy

Head of Biosafety, Non-clinical and Emerging Technologies 1 week ago Be among the first 25 applicants We are currently looking for a Head of Biosafety, Non-Clinical & Emerging Technologies to join our Benefit Risk Evaluation I Team within the Safety & Surveillance group. This is a full-time opportunity, on a permanent basis. Please be aware that this role can only be worked in the UK and not overseas. Government departments and agencies are working towards implementing a minimum 60% attendance in office sites. We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. 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. 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. Against this background and the drive to improve treatment availability for patients, safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying, assessing and managing the risks associated with medical products. In every aspect of this work, we harness the best science, technology, information and professional practice to protect patients in new and impactful ways. We are looking for an ambitious, forward-thinking leader to head the Biosafety, Non-Clinical & Emerging Technologies team. The role will suit an experienced clinician, academic or regulatory specialist with expertise in pre-clinical assessment, toxicology, genomics or in vitro diagnostics, and an interest in protecting patient safety. The post holder will lead the integration of scientific, clinical, and technical expertise to deliver high-quality benefit-risk assessments and ensure effective matrix working across the Benefit-Risk Evaluation functions, the wider Safety and Surveillance Group, and Agency lifecycle group. The role is pivotal in ensuring timely and robust responses to potential safety concerns, directly informing evidence-based regulatory decisions that uphold public health and product performance standards. Biological safety, and sterilisation and decontamination assessment: underpinning both post-market surveillance and clinical investigations for medical devices. Pharmacogenomics for pharmacovigilance: co-ordinate policy on the integration of pharmacogenomics with pharmacovigilance to support personalised medicine, ensuring our approach remains at the forefront of healthcare. Emerging technologies: lead policy on post-market surveillance and risk assessment of diagnostics, as well as emerging and advanced technologies such as nano-enabled medicines and devices, ATMPs (Advanced Therapy Medicinal Products), and synthetic biology products. Expertise in the relevant clinical, scientific, academic or technical field, including evidence of up-to-date specialist level of knowledge and evidence of analysis of data and preparation of reports, scientific publications or reviews or manuscripts for regulatory submissions is essential. Delivering at Pace: Evidence of ability to work in a pressurised, target driven environment, delivering results on time within a range of deadlines maintaining high standards of quality. Please use Chrome or Microsoft Edge. Online application form, including questions based on theBehaviour, Experience and Technical Success Profiles. In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of: expertise in the relevant clinical, scientific, academic or technical field, including evidence of up-to-date specialist level of knowledge and evidence of analysis of data and preparation of reports, scientific publications or reviews or manuscripts for regulatory submissions is essential. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own. If you require any disability related adjustments at any point during the process, please contact as soon as possible. Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules.Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks. Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. Laboratory-based roles working directly with known pathogens Maintenance roles, particularly those required to work in laboratory settings Roles that involve visiting other establishments where vaccination is required Roles required to travel overseas where specific vaccination may be required. Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.