Expert Quality Assessor

We are currently looking for a Expert Quality Assessor to join our Biologicals Unit within theHealthcare Quality and Access Group.

This is a fulltime 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 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

Reporting to the Team or function Manager Expert Assessors are required to assess the quality related aspects of product licensing initial and variation applications including those with new or very complex issues with widereaching implications. Expert Assessors will also make a high profile long term or strategic contribution to the Function and Agency through their wider activities.

Key responsibilities:

Assessment of Product Licensing Submissions

• Carry out the assessment of pharmaceutical quality data provided in marketing authorisation initial and variation applications and other procedures including those with novel very complex or sensitive issues with wideranging consequences making appropriate recommendations and decisions in line with the protection of public health.
• Manage own workload working in conjunction with business support and other assessors to meet International Agency or local deadlines
• Promptly update Agency or local work management databases to reflect the progress of own work
• Prepare and present objective assessments or other scientific papers to internal and external expert advisory bodies and committees
• Take a lead in providing influential reliable timely and appropriate scientific and regulatory advice to companies at meetings and in writing reflecting contemporary regulatory guidance and relevant regulatory decisions. Advice should be given in line with protection of public health and to promote innovation.

Sharing Knowledge and Development of Self and Colleagues

• Mentors or coaches other staff to enhance their knowledge and contribution and take a lead in the wider sharing of knowledge to colleagues
• Provides ad hoc advice to senior managers other parts of DHSC other governmental departments and bodies and ministers.
• Continues to extend and deepen skills and knowledge in relevant scientific or professional areas at the highest level to maintain an influential role in National and where relevant international decision making

Contribution to Policy and Procedures

• Initiate lead or influence guidelines procedures or policy and practice nationally and with international partners
• Anticipating where such changes are needed to minimise risks to the Agency and to benefit public health
• Effectively perform in a highlevel representational role outside the Agency.

Communication with Stakeholders

• Maintain good working relationships with colleagues and with internal and external stakeholders
• Effectively use a network of contacts to understand and operate within the wider political and government framework
• Deal effectively with sensitive or challenging official correspondence to agreed timelines

Management and Use of Resources

• Use own and Agency resources in line with Agency and divisional strategy to meet targets
• Anticipate resource needs to support initiatives or policy changes recommended

Who are we looking for Oursuccessful candidatewill have.

• Honours Degree in a relevant specialist subject.
• Detailed working knowledge and experience of national and European regulations and procedures applicable to the relevant area and evidence of being able to work within the wider governmental or international environment to achieve successful outcomes.
• Experience of working as a senior or leadsenior pharmaceutical/quality assessor having demonstrated a consistently high level of performance in that role and proven ability to handle a varied and challenging workload with high throughput commensurate with experience and knowledge to meet required timelines.
• Proven ability to evaluate and provide insight into the most complex novel sensitive or evolving issues with wideranging consequences under pressure using evidence or taking input from a variety of sources to make sound recommendations or decisions in line with the protection of public health.

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 a CVand statement of suitability attached as a PDF demonstrating how you meet the person specification.Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank.Please ensure not to include any personal identifying information on your supporting information.
• Interview which can include questions based on theBehaviour Experience Technical and Strengths Success Profiles.

Additional Information for Internal Applicants

Eligible applicants should discuss their intention/application and supporting statement with their line manager. Following the discussion the line manager and countersigning manager must complete theManagers Endorsement Form(Word)which isthen submitted by the internal applicant on as an attachment document.It is recommended that you allow your line manager at leastthree working days to complete this to ensure your application can be submitted on time.

To apply please submit an application via the Oracle Recruit system and attach the following documents:

• CV
• Supporting statement detailing how you meet the criteria marked with an A on the person specification
• Managers endorsement form

Use of AI in Job Applications

Applicants must ensure that anything submitted is factually 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 contact as soon as possible.

Closing date:22 May 2025

Shortlisting date: by 5 June 2025

Interview date:by 20 June 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 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