Regulatory Governance Expert
Regulatory Governance Expert
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
We are currently looking for aRegulatory Governance Expert to join ourInnovation and ComplianceFunction within the Healthcare Quality 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-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.We are open to requests for flexible working. Please discuss this with the recruiting manager before accepting an appointment.
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.
Whats the role
Provide lead advisory and guidance for senior managers and external enquirers in relation to compliance with the blood safety and quality regulations unlicenced medicines and the manufacture and wholesale distribution of human medicines including Advanced Therapy Medicinal Products (ATMPs) investigational medicinal products (IMPs) brokering of medicines the manufacture importation and distribution of active substances.
Key responsibilities:
Lead on ensuring the provision of timely high quality bespoke advice for senior managers inspectors and external enquirers in relation to implementation and interpretation with the blood safety and quality regulations unlicenced medicines and the manufacture and wholesale distribution of human medicines to ensure compliance as appropriate.
Lead on the provision of regulatory policy input into any existing and future legislation in these areas including providing Parliamentary briefings and support for Parliamentary debates
Coordinate working with Agency/HQA working groups Department of Health and Social Care and other government departments on matters relating to the work of the Regulatory Governance team
Engage with key stakeholders on issues affecting regulatory policy and input into the development of new strategies.
Represent the Agency at meetings of the
Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC)
Advisory Committee on the Safety of Blood Tissues and Organs
Lead on the development and publication of print and electronic versions of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors and Rules and Guidance for Pharmaceutical Distributors and other guidance as required.
Lead on forthcoming review of the Blood Safety and Quality Regulations and impact of the new EU human medicines directive on UK medicines legislation.
Deputise the role of chairing MHRAs Inspection Action Groups as required.
Coordinate updates to the electronic version of the guides where necessary and the timely negotiation of new risk-free publishing contract when required.
Quality and Assurance
Lead on instruction for legal services on requirements for new and amending legislation developing and implementing policy and obtaining legal advice.
Who are we looking for
Oursuccessful candidatewill demonstrate the following;
Seeing the big picture
Communicating and influencing
Delivering at Pace
Provision of regulatory advice
Provision of guidance
Detailed understanding of relevant aspects of the human medicines regulations (particularly in regard to unlicenced medicines and the manufacture and wholesale distribution) and the Blood safety and quality regulations.
If you would like to find out more about this fantastic opportunity please read our Job Description and Person Specification!
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description please contact
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 a detailed understanding of relevant aspects of the human medicines regulations (particularly in regard to unlicenced medicines and the manufacture and wholesale distribution) and the Blood safety and quality regulations.
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:4th September 2025
Shortlisting date: 5th September 2025
Interview date:from 22nd September2025
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.
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
Employment Type
Full-Time
