Senior Regulatory Affairs Advisor - Clinical Investigations & Policy

We are currently looking for a Senior Regulatory Affairs Advisor - Clinical Investigations & Policy to join our Clinical Investigations Team within the Science, Research & Innovation 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. 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 Science, Research and Innovation Group delivers public health impact, world-leading research innovation, and a unique regulatory proposition for patients and users via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.

What's the role?

The core purpose of the role is to provide support for the Agency's role in reviewing and approving clinical investigations. The role will be responsible for supporting senior management with the coordination of clinical investigation assessments and be a key player in the continued development and implementation of the future regulation. The role will also have responsibility for supporting a review of the MHRA's role in the overall clinical investigations process across research ethics committees and the Health Research Authority amongst others. An added focus will be working on trialling combined MHRA Medicines & Device trials applications through a single route and further development of a recent pilot of a coordinated application route with the Health Research Authority.

Key responsibilities:

• Provide regulatory advice and guidance regarding the implementation and interpretation of the current and future Clinical Investigations regulatory regime.
• Assist in the delivery of aspects of new regulation and guidance, as directed by the Head of Clinical Investigations.
• Acting as a regulatory handler of clinical investigations, communicating clearly with manufacturers and assessors, ensuring the Agency is providing a clear and efficient service.
• Training of regulatory handlers/advisors and assessors, both internal and external, to conduct assessments that meet the requirements set out within legislation.
• Support senior management in developing and maintaining a strategy for providing manufacturers with advice on clinical evaluation. This will include engagement with key stakeholders including NIHR, NOCRI and NICE to expand this strategy.

Who are we looking for?

Our successful candidate will have:

• A university degree in a relevant subject (e.g. life sciences) or equivalent knowledge/experience gained in the medical and/or regulatory sectors.
• Significant experience working in medical device regulatory affairs or for medical device manufacturers.
• Significant experience of policy development in a regulatory environment. Proven ability to understand and assess the impact of policy and regulatory change.
• Significant working knowledge and understanding of the Medical Device Regulations.

The selection process:

We use the Civil Service Success Profiles to assess our candidates.

• 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 Experience - Significant experience of policy development in a regulatory environment. Proven ability to understand and assess the impact of policy and regulatory changes.

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.

Closing date: 23 March 2025

Shortlisting date: W/C 24 March 2025

Interview date: 4 April 2025

Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.