Regulatory Governance Lead

MHRA; Greater London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A healthcare regulatory agency is seeking a Regulatory Governance Lead to join the Operational Delivery Function in London. This full-time role involves providing regulatory advice regarding human medicines and policy development. Candidates should have experience with UK legislation and excellent communication skills. This position supports a hybrid working model with required on-site attendance. The application deadline is December 23, 2025, with interviews beginning January 12, 2026.

Qualifications

• Experience providing advice on UK legislation relating to human medicines.
• Proven ability to communicate and influence stakeholders.
• Demonstrable competence in interpreting legislation.

Responsibilities

• Provide guidance on UK legislation for human medicines.
• Develop instructions for legal services regarding new legislation.
• Publish annual rules and guidance for pharmaceutical practices.

Skills

Providing regulatory advice

Communicating and influencing

Seeing the big picture

Working together

Job description

Regulatory Governance Lead – Operational Delivery Function, Healthcare Quality and Access Group

We are currently looking for a Regulatory Governance Lead to join our Operational Delivery Function within the Healthcare Quality and Access Group. This is a full‑time, permanent opportunity. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. 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 implementing a flexible, hybrid way of working, with a minimum of 8 days per month on site to enable collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs and can flex up to 12 days per month, with the remainder of time worked remotely or in the office.

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.
• Develop 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?

• 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)

Selection process

We use the Civil Service Success Profiles to assess our candidates. The process includes an online application form with questions based on the Behaviour, Experience and Technical Success Profiles, followed by an interview that may include questions based on all Success Profiles. If a high number of applications is received, an initial sift will be based on the lead criteria of candidates demonstrating experience of providing advice on UK legislation relating to medicines.

Applicants will be 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 read them thoroughly.

Important information

• Applicants must meet UK immigration requirements and Civil Service nationality rules.
• Successful candidates must pass a disclosure and barring security check, animal rights and pro‑life activism checks, and may be subject to personnel security standard checks.
• Vaccination and health surveillance may apply to certain roles.
• Applicants subject to an Internal Fraud Database check. A candidate is not eligible to apply if dismissed for fraud within five years.

Closing date: 23rd December 2025

Shortlisting date: 5th January 2026

Interview date: 12th January 2026

For any questions or assistance applying for this role, please contact [e-mail]

We are an equal opportunity employer. If you require any disability‑related adjustments at any point during the process, please contact [e-mail] as soon as possible.