We are currently looking for a Scientific & Procedure Advisor to join our Authorisation Lifecycle Function within the Health Quality and Access group.
We have two full‑time opportunities, one on a permanent basis and one fixed term contract for a period of 12 months. Internal move, temporary promotion or loans will be considered. 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.
The Medicines and Healthcare products Regulatory Agency enhances and improves the health of millions of people everyday through effective regulation of medicines and medical devices, underpinned by science and research.
The objective of the Healthcare Quality and Access portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It brings together capabilities across medicines and medical devices to enable authorisation and market access, while ensuring compliance with regulations and standards.
The Authorisation Lifecycle function is an enabler, central to the delivery of the frontline HQA group. It includes data assurance and quality, high‑volume certification work and coordination and support to frontline functions. It also supports more complex activities across the product lifecycle such as medicines and medical devices, borderline, patient information and medicines advertising.
What’s the role?
The post holder is required to assess the accuracy of documents and data held on internal databases to support applications following initial assessment, assess some variations and abridged simple applications, and communicate with and provide advice to internal and external stakeholders as required.
Key responsibilities:
- Perform compliance assessments (checking product information on MHRA systems) for new marketing authorisation applications.
- Assess Regulation 56 (formerly Article 10c) marketing authorisation applications.
- Assess variations subsequent to the grant of a marketing authorisation.
- Work collaboratively to drive continuous improvement within the group.
Who are we looking for?
Our successful candidate will have the following:
- A degree in chemistry, pharmacology or another scientific discipline, or relevant experience.
- A working knowledge of the documentation required to support a marketing authorisation application in the UK and Europe.
- Effective communication skills with internal and external stakeholders, with the ability to clearly explain information verbally and in written communication.
- Strong organisational skills, attention to detail and analytical or assessment skills, including the ability to make sound decisions while working to tight deadlines.
- A proactive approach to problem solving in a multidisciplinary, target‑oriented team.
Person Specification:
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
- Working Together – A proactive approach to problem solving in a multidisciplinary, target‑oriented team. (A, I)
- Communicating & Influencing – Ability to communicate effectively with internal and external stakeholders, with proven ability to clearly explain information verbally and by written communication. (A, I)
- Making Effective Decisions – Good organisational skills, attention to detail and analytical or assessment skills, including making sound decisions while working to tight deadlines. (A, I)
Experience Criteria:
- A degree in chemistry, pharmacology or another scientific discipline, or relevant experience. (A)
- A working knowledge of the documentation required to support a marketing authorisation/PLPI application in the UK and Europe. (A, I)
Technical Criteria:
- Good information management and technology skills, including preparation and maintenance of Word and Adobe documents, spreadsheets and reference databases, and high competence in the agency’s custom Sentinel system. (A, I)
- Understanding of relevant legislation, guidance and procedures used to obtain or change a marketing authorisation (Scientific and Procedure Advisor – MA specialists), or obtain, change (variation) or renew a PLPI authorisation (Scientific and Procedure Advisor – PLPI specialist). (A, I)
If you require any disability related adjustments during the process, please contact careers@mhra.gov.uk.
Successful candidates must pass a disclosure and barring security check, as well as remaining abstract checks and routine health surveillance when required.
Scientific & Procedure Advisor employer: Medicines and Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an exceptional employer, offering a dynamic work environment in the heart of Canary Wharf, London. With a strong commitment to employee growth, the agency provides opportunities for professional development and collaboration with leading experts in healthcare and research. The hybrid working model promotes a healthy work-life balance, while the agency's focus on innovation and public health ensures that employees contribute to meaningful projects that enhance the well-being of millions.
Contact Details:
Medicines and Healthcare Products Regulatory Agency Recruitment Team
