Job Description
We are currently looking for a R egulatory Governance Lead to join our Operational Delivery Function within the Healthcare Quality and Access 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 objective of the Innovation and Compliance Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated patient access pathways.
The Standards & Compliance function enables innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratories, the Compliance Teams (inspectors), the Inspection Action Group and Devices Audit and Compliance.
What’s the role?
Provides advice and guidance to internal and external enquirers on UK legislation relating to the manufacture, assembly and importation and wholesale distribution of medicinal products, investigational medicinal products, unlicensed medicines brokering of medicines, and the manufacture, importation and distribution of active substances.
Key Responsibilities
Provide and contribute to guidance and advice on UK legislation relating to the manufacture and wholesale distribution of human medicine, including Advanced Therapy Medicinal Products (ATMPs), investigational medicinal products (IMPs) and unlicensed medicines, brokering of medicines, and the manufacture, importation and distribution of active substances.
Participate In
* Developing instruction for legal services on requirements for new and amending legislation, developing and implementing policy and obtaining legal advice.
* The development and publication of an annual print version and electronic version of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors and Rules and Guidance for Pharmaceutical Distributors.
* Consult and liaise with the Department of Health and Social Care, other Government Departments, professional advisers, and industry representatives.
* Service improvement with input into development of updates to the electronic version of the guides where necessary and the timely negotiation of new risk-free publishing contract when required
Who are we looking for?
Our successful candidate will demonstrate the following.
* Seeing the big picture
* Working together
* Communicating and influencing
* Delivering at Pace
* Provision of regulatory advice
* Provision of guidance
Person Specification
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria
* Working Together (A, I)
* Managing a Quality Service (A, I)
* Communicating and Influencing (A, I)
* Seeing the Big Picture (A, I)
Experience Criteria
* Experience of providing advice on UK legislation relating to human medicines, to internal and external stakeholders, with particular reference to manufacture and wholesale
Technical Criteria
* Demonstrable competence in considering, interpreting and explaining legislation. (A, I)
Strengths Criteria
* Resilient (I)
* Relationship Builder (I)
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.
* 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 candidates demonstrating e xperience of providing advice on UK legislation relating to medicines.
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.
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: 23 rd December 2025
Shortlisting date: from 5 th January 2026
Interview date: from 12 th January 2026
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 .
Role
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 Oleylami, 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
info@csc.gov.uk
Civil Service Commission
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1 Horse Guards Road
London
SW1A 2HQ
About Us
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.