Regulatory Governance Lead

We are currently looking for aRegulatory Governance Leadto join ourOperational Delivery Function within the HealthcareQuality and Access Group.

Please note this opportunity is currently only available to those working within the Civil Service. Applications from non-Civil Servants may not be reviewed and may be rejected.

This is a full-timeopportunity 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 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.

Whats the role

This roleprovides 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:

Candidates will 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

Oursuccessful candidatewill demonstrate the following.

Behaviour - Working Together
The post-holder will be able to work effectively and efficiently as part of a small team to tight post-holder will have good organisational skills.

Behaviour - Communicating and influencing
The post-holder will have excellent communication skills both written and oral. Able to establish co-operative working relationships with a variety of different people and organisations.

Behaviour - Managing a Quality Service

Work efficiently and to tight deadlines. Good organisational skills.

Strength
The post-holder will be resilient and able to buildlong lasting relationships and deliver high quality consistent outputs at pace and with the enthusiasm and energy.

Technical
The post-holder will be able to demonstrate a broad ability in interpreting legislation.

Experience
The post-holder will have experience of providing advice on UK legislation relating to medicinesand be able to demonstrate a knowledge and understanding of the manufacture assembly importation and wholesale distribution of medicinal products investigational medicinal products unlicensed medicines brokering of medicines and the manufacture importation and distribution of active substances.

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 candidatesfind out more here.

• Online application form including questions based on theBehaviour 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 theBehaviour 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 having experience 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 allowsufficienttime. 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 as soon as possible.

Closing date:11^th November 2025

Shortlisting date: from 18^th November 2025

Interview date: from 25^th November 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 questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

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 completebasic 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 applicants 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 eligibilityhere.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit 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 OleylamiHead of Talent Acquisition.

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ