Regulatory Governance Lead

Medicines and Healthcare products Regulatory Agency; City Of London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A UK Health Regulatory Agency is seeking a Regulatory Governance Lead to provide expertise on UK legislation regarding medicinal products. The role involves guidance on manufacturing standards and legislative support. Candidates should have experience in UK medicinal legislation and strong communication capabilities. This position is full-time and offers a hybrid working model with a minimum of 8 days on site per month.

Qualifications

• Experience providing advice on UK legislation relating to the manufacture and distribution of medicinal products.
• Strong communication skills, both written and oral.
• Ability to work efficiently under tight deadlines.

Responsibilities

• Provide guidance on legislation relating to the manufacture and distribution of medicinal products.
• Develop instructions for new legislation and obtain legal advice.
• Publish annual versions of guidance documents.

Skills

Teamwork

Communication

Organizational skills

Relationship building

Interpreting legislation

Education

Experience with UK legislation relating to medicines

Job description

Description

We are currently looking for a Regulatory Governance Lead to join our Operational Delivery Function 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.

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.

Who are we

The Medicines and Healthcare products Regulatory Agency enhances and improves 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.

Role

This 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 ATMPs, IMPs, 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.
• Develop and publish an annual print version and electronic version of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors and for Pharmaceutical Distributors.
• Consult and liaise with the Department of Health and Social Care, other Government Departments, professional advisers and industry representatives.
• Improve service by updating the electronic version of the guides where necessary and negotiating new risk‑free publishing contracts.

Behaviour, Technical & Experience

• Behaviour – Working Together: Work effectively and efficiently as part of a small team and manage organisational skills.
• Behaviour – Communicating and influencing: Excellent communication skills, both written and oral, and ability to establish cooperative working relationships.
• Behaviour – Managing a Quality Service: Work efficiently, meet tight deadlines and maintain good organisational skills.
• Strength: Resilient, able to build long‑lasting relationships and deliver high quality consistent outputs with enthusiasm and energy.
• Technical: Broad ability in interpreting legislation.
• Experience: Experience providing advice on UK legislation relating to medicines, with knowledge of the manufacture, assembly, importation and wholesale distribution of medicinal products, investigational medicinal products, unlicensed medicines, brokering of medicines and active substances.

Selection process

We use the Civil Service Success Profiles to assess our candidates and will look for competence in the Behaviour, Experience and Technical Success Profiles. Applications are scored and a sift will be conducted based on the lead criteria.

Interview may include questions on the behaviour, experience, technical and strengths success profiles.

Applicants will be scored on competency‑based answers. If we receive a high number of applications an initial sift will be made.

Closing and dates

Closing date: 11th November 2025

Shortlisting date: from 18th November 2025

Interview date: from 25th November 2025

Additional information

Applicants are subject to UK immigration requirements and Civil Service nationality information. Successful candidates must pass a disclosure and barring security check as well as animal rights and pro‑life activism checks.

Certain roles may require vaccinations and routine health surveillance, including laboratory‑based roles, maintenance roles in laboratory settings, roles that involve visiting other establishments where vaccination is required and roles that require overseas travel with specific vaccination requirements.

For assistance applying or for any other questions, please contact contact details.

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.

If you are not satisfied with the response you receive you can contact the Civil Service Commission at: Civil Service Commission, Room G/8, 1 Horse Guards Road, London, SW1A 2HQ.