We are currently looking for a Regulatory Science Specialist to join our Innovation Accelerator and Regulatory Science Function within the Scientific Research and Innovation 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. 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. Some roles will need to be on site more regularly.
Who are we?
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 Scientific Research and Innovation Group delivers public health impact, world-leading research innovation, and a unique proposition via its Science Strategy. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.
The Innovation Accelerator helps provide innovators access to MHRA scientific expertise and regulatory guidance, helping developers of innovative products (medicines, medical devices (including software) and blood components for transfusion) connect more dynamically with an enhanced advice and signposting service. It brings together the MHRA Innovation Office, the Regulatory Advice Service for Regenerative Medicines (RASRM), Regulatory Science and horizon scanning. It also leads for MHRA on the delivery of the Innovative Licensing and Access Pathway (ILAP) and Innovative Devices Access Pathway (IDAP).
The Innovation Accelerator is evolving with increased focus on driving MHRA policy development to support novel and potentially transformative that healthcare products, so they benefit from the regulatory support to optimise their route to market. It will act to ensure MHRA can play its role as an enabler for delivering growth and supporting the Government priorities supporting UK Life Sciences agenda and how to harness the critical technologies outlined in the UK Science and Technology Framework.
The role offers an exciting opportunity to be at the forefront of healthcare innovation in the UK. The successful candidate will deliver subject matter expertise in healthcare products regulation derived from their experience across the drug/device development lifecycle. The successful candidate will leverage this knowledge and experience by providing advice to support the function of the IA, Regulatory Science and the wider Agency.
Deliverables will include practical interpretation of horizon scanning signals, strategic input into regulatory science activities contributing to projects across the range of the Innovation Accelerator responsibilities which reach across the whole of the Agency’s work, and development of responses to regulatory enquires (and related activities). The role is regularly required to work at pace on multiple areas, develop creative solutions based on their in-depth regulatory expertise and deal with competing priorities.
What’s the role?
The Regulatory Science Specialist will be collaborating with technical experts across the MHRA, the Department of Health and Social Care (DHSC) and other organisations in the health eco system including the life sciences industry. The role holder will use their knowledge of regulatory frameworks and how these apply to areas of emerging innovation to identify where these may affect the MHRA and prepare responses as necessary. We are looking for an experienced regulatory expert, who is seeking a fast-paced, varied role, working on emerging innovation, which demands the ability to get to the heart of technical issues quickly where there is significant ambiguity and be adaptable to operate with a high degree of flexibility.
Key responsibilities:
- Provide leadership as the Innovation Accelerator’s specialist in medicine and medical device regulation, apply regulatory expertise and knowledge to support the function providing expert regulatory advice to external stakeholders / requesters, ensuring that the advice adds value to the information that is currently available in the public domain and signposts to MHRA services.
- Lead and contribute to driving forward the development of cross-cutting strategy, policy and guidance, working with other MHRA technical experts, contributing to MHRA’s wider innovation strategy by informing decisions on the case for change through use of evidence, providing advice and briefings to senior leaders on a variety of matters relating to the regulation of innovative healthcare products. This will include playing a key role in developing regulatory pathways that can optimise the development of new innovative products and technologies.
- Develop good working relationships across the MHRA and across related organisations with a strong appreciation of the wider roles and remits, to bring together different views understand regulatory and technical challenges to maximize the impact of our work for the benefit of patients and the public.
- Monitor the broader regulatory landscape relating to innovative product and regulatory environment in order to provide advice and insight to steer, prioritise, and maximise the impact of the MHRAs activities. This will include preparing and presenting high-quality briefing and guidance documents, communicating complex issues into clear and concise policy recommendations, and advising senior officials and support key decision making.
Who are we looking for?
Our successful candidate will demonstrate the following civil service success profiles:
- Behaviour – Leadership
- Behaviour – Seeing the Big Picture
- Behaviour – Communicating and Influencing
- Behaviour – Making Effective Decisions
- Experience - Broad and expert regulatory experience in innovative medicines and/or devices in a regulatory or industry setting.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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The selection process:
We use the Civil Service Success Profiles to assess our candidates, find out more here.
Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths 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 Seeing the Big Picture.
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.
Use of AI in Job Applications
Applicants must ensure that anything submitted is factually accurate and truthful. 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 careers@mhra.gov.uk as soon as possible.
Closing date: 27 July 2025
Shortlisting date: w/c 04 August 2025
Interview date: w/c 18 August 2025
Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.
If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.
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. These roles include:
- 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. Any applicant’s details held on the IFD will be refused employment. 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.
Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.
Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.
In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Florentina Oyelami, Head of Talent Acquisition, Florentina.Oyelami@mhra.gov.uk.
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
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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.
The agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.
The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.