Location
10 South Colonnade, Canary Wharf, London, E14 4PU. This role must be worked within the UK only.

Hours
Full Time. Flexible hybrid working with a minimum of 8 days per month on site, which may flex up to 12 days depending on business needs.

Salary
Negotiable

About the Role
We are seeking a Scientific & Procedure Advisor to join the Authorisation Lifecycle Function within the Health Quality and Access group at the Medicines and Healthcare Products Regulatory Agency (MHRA). There are two full-time opportunities available: one permanent and one fixed term contract for 12 months. The role supports the effective regulation of medicines and medical devices by assessing the accuracy of documents and data held on internal databases to support applications following initial assessment. Responsibilities include compliance assessments for new marketing authorisation applications, assessment of Regulation 56 (formerly Article 10c) marketing authorisation applications, and assessment of variations subsequent to the grant of a marketing authorisation. The post holder will also provide advice and communicate with internal and external stakeholders and work collaboratively to drive continuous improvement within the group. The role is central to delivering the frontline HQA group’s objectives by ensuring quality, compliance, and robust decision-making across the product lifecycle for medicines and medical devices.

Experience
- A degree in chemistry, pharmacology or other scientific discipline, or relevant experience
- Working knowledge of documentation required to support marketing authorisation applications in the UK and Europe
- Experience with compliance assessments and regulatory procedures is desirable

About you
- Able to communicate effectively with internal and external stakeholders, with proven ability to clearly explain information verbally and in writing
- Good personal work organisation, attention to detail, and strong analytical or assessment skills
- Ability to make sound decisions while working to tight deadlines
- Proactive approach to problem solving within a multidisciplinary, target-oriented team

Qualifications
- Degree in a relevant scientific discipline or equivalent experience
- Good information management and technology skills, including preparation and maintenance of Word and Adobe documents, spreadsheets, and reference databases
- High level of competence in using agency systems such as the custom Sentinel system
- Understanding of relevant legislation, guidance, and procedures for obtaining or changing marketing authorisations or PLPI authorisations