DescriptionWe are currently looking for aDeputy Director National Licensing Strategyto join ourNational Licensing Strategy Functionwithin theHealthcare Quality and Access group.
This is afulltimeopportunity on apermanentbasis. 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 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 Healthcare Quality and Access group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access as well as ensuring compliance with regulations and standards.
Whats the role
You will lead a team to develop and implement new licensing approaches to facilitate early access to safe effective and highquality medicinal products with a strategic focus on UK public health priorities and unmet clinical need. The role will encompass Innovative and Established Medicines linking with device requirements to ensure joinup and consistency of approach. You will recognize the MHRAs ambition to be a leading global regulator while understanding that international recognition and collaborative worksharing can deliver efficiency and promote global harmonization. You will work collaboratively with colleagues across HQA and the wider Agency.
Key responsibilities:
- Develop and implement a new national regulatory framework for the licensing of innovative and established medicinal products. This will deliver reliable and predictable performance for all licensing applications while providing the regulatory tools to support faster patient access where there is high unmet clinical need.
- Lead on the development of a prioritization framework for the assessment of medicines that fulfil high unmet clinical need including innovative and transformative medicines incorporating UK government health priorities.
- Cooperate with UK partner organizations including health technology assessment bodies the NHS and devolved nations to align and coordinate patient access pathways across the system.
- Work with international partners to further optimize collaborative pathways including Access and Project Orbis to improve uptake increase efficiency share best practice and harmonize standards where possible to enable faster patient access via these routes.
- Identify licensing areas that require or would benefit from legislative reform and work with Partnerships DHSC and the Government Legal Department to implement legal updates.
- Engage with developers and work with the HQA presubmission advice team to identify potentially transformative pipeline medicines that require a novel regulatory approach.
- Ensure that all licensing guidance is aligned with legislation and current regulatory practice providing clarity to external stakeholders and reducing the need for individual regulatory queries.
- Undertake a comprehensive review of international scientific guidelines adopting and implementing where appropriate. Work across HQA to develop national scientific guidelines to support gaps or divergence or to facilitate the development and licensing of novel therapies.
Who are we looking for
Oursuccessful candidatewill:
- Demonstrate Regulatory knowledge and understanding of the framework in which the department operates and the impact of decisions being made.
- Leadership Remain visible and approachable to all colleagues and stakeholders. Actively promote the reputation of the organisation with pride both internally and externally. Display passion and enthusiasm for the work helping to inspire colleagues and stakeholders to fully engage with the aims and longterm vision
- Understand the regulatory landscape with a deep knowledge of international regulation.
- Have a significant record of delivery against challenging objectives and leading change at a senior level and the confidence/ability to work in a pressurized target driven environment.
- Relationship Builder You quickly establish mutual respect and trust building long lasting relationships with others.
If you would like to find out more about this fantastic opportunityplease 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.
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 competencybased 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 isfactually 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 contactas soon as possible.
Closing date:5th May 2025
Shortlisting date: week commencing 6th May 2025
Interview date:week commencing 19th May 2025
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 prolife activism checks. People working with government assets must completebasic personnel security standard checks.
Applicants who are successful at interview will be as part of preemployment 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 TaxFree 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
