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About the Role

Data Assurance & Quality (DAQ) Classifiers interpret and validate regulatory submissions from pharmaceutical industry applicants, applying medicines legislation, regulations, and guidelines. In some areas, they make final decisions on application validity; in others, they prepare case folders for professional assessment. This is a target-driven environment where speed, quality, and consistency are vital. DAQ Classifiers must confidently interact with professional colleagues and external applicants.

Responsibilities

• Support the delivery of three core activities for DAQ unit functioning.
• Take ownership and responsibility of own training and development activities.
• Fully comply with SOPs and Unit guides in completion of daily activities, highlighting any issues or concerns to Senior Classifier/Delivery Manager.
• Work with DAQ operational managers in identifying process issues and solutions.

Requirements

• Proven organizational skills and a demonstrable track record working to deadlines in a pressurized, target-driven environment, while maintaining high standards of quality.
• Demonstrate knowledge and interpretation of the regulatory procedures surrounding the licensing of medicinal products in the UK and Europe.
• Relevant experience reviewing complex scientific and regulatory documentation and dealing with databases, to ensure high standards of data quality and accuracy.
• Demonstrate experience of communicating complex medical or regulatory information clearly and accurately to applicants and professional colleagues.
• Relevant Life Sciences Degree or significant equivalent experience in a related area.

Skills

• Organizational skills
• Working to deadlines
• Quality assurance
• Regulatory procedure interpretation
• Scientific documentation review
• Database management
• Data quality assurance
• Data accuracy
• Communication of complex medical information
• Communication of regulatory information

Location

• 10 South Colonnade, Canary Wharf London, E14 4PU, UK

Work Type

• Full-time
• Permanent
• Hybrid

Experience Level

• Not specified

Education Level

• Relevant Life Sciences Degree or significant equivalent experience

About the Company

• 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 agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.
• The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.

Equal Opportunity

• 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.