Licensing – Pharmaceutical Assessor
- Experience Level
- Experienced (non-manager)
We are currently looking for a Pharmaceutical Assessor to join one of our Product Lifecycle Assessment Teams within the Licensing division.
This is a full-time opportunity, on a permanent basis.
Who are we?
The Medicines and Healthcare products Regulatory Agency enhances and improves the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
The Licensing Division within the Medicines and Healthcare products Regulatory Agency is responsible for assessing and approving applications for marketing authorisations. These may be for new medicinal products (new active substances), new routes of administration or new formulations of existing drugs, generic drugs, parallel import applications, or herbals and homeopathic products. In addition, the Licensing Division has the responsibility for assessing and granting clinical trial authorisations.
What’s the role?
Pharmaceutical Assessors assess the quality aspects of both initial and variation applications for marketing authorisations for medicinal products and take decisions on their suitability for approval.
The role encompasses a broad range of activities from assessing an application for a new active substance, a novel dosage form, or a generic medicine, to providing scientific advice to companies around pharmaceutical/regulatory issues for development of new drug products.
- Carry out the assessment of data provided in marketing authorisation initial and variation applications for chemical products making appropriate recommendations and decisions in line with the protection of public health.
- Prepare and present objective assessments or other scientific papers to expert advisory bodies.
- Manage own workload working in conjunction with service coordinators and other assessors to meet agency deadlines.
- Provide ad hoc advice to colleagues in the Division or Agency.
- Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
Who are we looking for?
Our successful candidate will:
- Have up to date specialist knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture and quality control of human medicinal products.
- Have in-depth knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
- Hold a degree in pharmacy and registration with the GPhC or be eligible to be registered with the GPhC through equivalent registration body for pharmacists in another EC country.
- Be able to work flexibly, with the ability to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Have significant and extensive experience in at least one of the following areas; regulatory affairs, research and development, or manufacture or quality control of medicinal products within academia, the pharmaceutical industry or hospital pharmacy.
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 candidates, find out more here.
- 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.
- A written test will be set at part of the interview process, relevant information will be supplied on the day.
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
If you require any disability related adjustments at any point during the process, please contact firstname.lastname@example.org as soon as possible.
Closing date: 15th February 2021
If you need assistance applying for this role or have any other questions, please contact email@example.com
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.
Our process requires that you apply through our careers site, where you will be asked to complete your application and answer some competency based questions. Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applicants are scored on their competency answers so please ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.
In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit 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 Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@mhra.gov.uk.
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
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