Regulatory Science Specialist

Deliverables will include practical interpretation of horizon scanning signals strategic input into regulatory science activities contributing to projects across the range of the Innovation Accelerator responsibilities which reach across the whole of the Agencys work and development of responses to regulatory enquires (and related activities). The role is regularly required to work at pace on multiple areas develop creative solutions based on their in-depth regulatory expertise and deal with competing priorities.

Whats the role

The Regulatory Science Specialist will be collaborating with technical experts across the MHRA the Department of Health and Social Care (DHSC) and other organisations in the health eco system including the life sciences industry. The role holder will use their knowledge of regulatory frameworks and how these apply to areas of emerging innovation to identify where these may affect the MHRA and prepare responses as necessary. We are looking for an experienced regulatory expert who is seeking a fast-paced varied role working on emerging innovation which demands the ability to get to the heart of technical issues quickly where there is significant ambiguity and be adaptable to operate with a high degree of flexibility.

Key responsibilities:

• Provide leadership as the Innovation Accelerators specialist in medicine and medical device regulation apply regulatory expertise and knowledge to support the function providing expert regulatory advice to external stakeholders / requesters ensuring that the advice adds value to the information that is currently available in the public domain and signposts to MHRA services.

• Lead and contribute to driving forward the development of cross-cutting strategy policy and guidance working with other MHRA technical experts contributing to MHRAs wider innovation strategy by informing decisions on the case for change through use of evidence providing advice and briefings to senior leaders on a variety of matters relating to the regulation of innovative healthcare products. This will include playing a key role in developing regulatory pathways that can optimise the development of new innovative products and technologies.

• Develop good working relationships across the MHRA and across related organisations with a strong appreciation of the wider roles and remits to bring together different views understand regulatory and technical challenges to maximize the impact of our work for the benefit of patients and the public.

• Monitor the broader regulatory landscape relating to innovative product and regulatory environment in order to provide advice and insight to steer prioritise and maximise the impact of the MHRAs activities. This will include preparing and presenting high-quality briefing and guidance documents communicating complex issues into clear and concise policy recommendations and advising senior officials and support key decision making.

Who are we looking for

Oursuccessful candidatewill demonstrate the following civil service success profiles:

• Behaviour Leadership

• Behaviour Seeing the Big Picture

• Behaviour Communicating and Influencing

• Behaviour Making Effective Decisions

• Experience - Broad and expert regulatory experience in innovative medicines and/or devices in a regulatory or industry setting.

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.

Presentation to be prepared as part of your interview with further information being supplied when you reach this stage.

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 Seeing the Big Picture.

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

• 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 eligibility here.

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 Oyelami 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

1Horse Guards Road

London

SW1A 2HQ