Job summary
We are currently looking for aQuality Assessorto join ourInnovative MedicinesTeam within theHealthcare Quality and Accessgroup.
This is afull-timeopportunity, on apermanent. 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. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 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 8 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.
TO BE CONSIDERED FOR THIS ROLE, PLEASE APPLY ON MHRA (http://lhrc1a.rfer.us/MHRAArV1GB)WEBSITE
ONLY APPLICATIONS MADE ON MHRA WEBSITE WILL BE CONSIDERED
Main duties of the job
The post holder will be part of the Biological Products Team, reporting to one of the Heads of Teams. Quality Assessors assess the quality of both initial and variation marketing authorisation applicationsfor biological medicinal products and take decisions on their suitability for approval. Examples ofBiological products can include monoclonal antibodies, gene and cell therapy products, blood derived products, vaccines.
The role encompasses a broad range of activities from assessing an application for a new active substance, a line extension, or a biosimilar, to providing scientific advice to companies around quality/regulatory issues for the development of new drug products.
About us
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.
Job description
Job responsibilities
Key responsibilities:
- Carry out the assessment of data provided in initial and variation marketing authorisation applications for biological products, making appropriate recommendations and decisions in line with the protection of public health.
- Prepare and present objective risk-based assessments or other scientific papers to expert advisory bodies.
Manage own workload, working in conjunction with managers, support staff and other assessors to meet agency deadlines.
- Contribute to assessment policy and practice and proactively identify where such contributions would be beneficial.
- Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases.
- Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
Job description
Job responsibilities
Key responsibilities:
- Carry out the assessment of data provided in initial and variation marketing authorisation applications for biological products, making appropriate recommendations and decisions in line with the protection of public health.
- Prepare and present objective risk-based assessments or other scientific papers to expert advisory bodies.
Manage own workload, working in conjunction with managers, support staff and other assessors to meet agency deadlines.
- Contribute to assessment policy and practice and proactively identify where such contributions would be beneficial.
- Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases.
- Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
Person Specification
Experience
Essential
- 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 biological medicinal products.
- Have a working knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
- Hold a degree in pharmacy, biology, biological sciences, medicine or a related field with relevant postgraduate experience or PhD equivalent.
- Be able to work flexibly, with the ability to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Experience within the pharmaceutical industry, hospital pharmacy or academia (or equivalent) in at least one of the following areas: regulatory affairs, research and development, or manufacture or quality control of biological medicinal products.
Person Specification
Experience
Essential
- 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 biological medicinal products.
- Have a working knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
- Hold a degree in pharmacy, biology, biological sciences, medicine or a related field with relevant postgraduate experience or PhD equivalent.
- Be able to work flexibly, with the ability to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Experience within the pharmaceutical industry, hospital pharmacy or academia (or equivalent) in at least one of the following areas: regulatory affairs, research and development, or manufacture or quality control of biological medicinal products.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
