Description
The Regulatory Information Officer is responsible for acting as the regulatory data steward for Essential Pharma Group’s licence portfolio across the UK, EU, Switzerland and Rest of World markets. They will make sure the licence and product data held in our Regulatory Information Management (RIM) system, and submitted to health authority databases such as EMA xEVMPD, SPOR and the PLM portal, is accurate, complete and ready for inspection at all times. If you are keen to join a patient centric, high-growth company, then read on and apply today!
Requirements
Qualifications
- Degree in a life science, information management or related discipline, or equivalent practical experience in a regulated environment
Experience
- Experience using or supporting RIM, electronic document management or similar database systems (for example Veeva Vault)
- Knowledge of EU regulatory data standards and databases, such as xEVMPD (Article 57), SPOR and IDMP, is desirable
- Experience in document, records or data management within a regulated (GxP) environment, ideally pharmaceutical regulatory affairs
- Familiarity with regulatory procedures and document types, such as marketing authorisations, variations, renewals, SmPCs and PILs, is desirable
- Advanced user of Microsoft Excel, Word, SharePoint and Teams
Core Competencies
- Demonstrate a Growth mindset and willingness to learn
- Adapt to situations of high-speed change
- Solve problems and bring structure to complex information
- Demonstrate integrity and high ethical standards
- Demonstrates a willingness to achieve goals together and respect the view of others
- Results orientated and accountable for actions
- Excellent attention to detail and accuracy in data and document handling
- Organised and methodical, with the ability to manage multiple priorities and deadlines
- Strong interpersonal skills and understanding of team dynamics
- Excellent written and verbal communication skills in English language
