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About the Role

The Non-clinical Assessor will assess the pre-clinical aspects of clinical trial and marketing authorisation applications for medicinal products and take decisions on their suitability for approval.

Responsibilities

• Carry out the assessment of data provided in clinical trial authorisation and marketing authorisation applications for chemical and biological products making appropriate recommendations and decisions in line with the protection of public health.
• Involvement in multiple Licensing pathways (ILAP, IRP, etc) and provision of scientific advice on the non-clinical aspects of drug development.
• Manage own workload working in conjunction with service coordinators and other assessors to meet agency deadlines.
• Prepare and present objective assessments or other scientific papers to expert advisory bodies.
• Develop to provide ad hoc advice to colleagues in the Division or Agency.
• Extend and deepen skills and knowledge in relevant scientific or professional areas.
• Contribute to assessment policy and practice and proactively identify where such contributions would be beneficial.
• Contribute to divisional procedures and proactively identify where such contributions would be beneficial.

Requirements

• Substantial experience in at least one of the following: toxicology or non-clinical regulatory affairs within the pharmaceutical industry, governmental departments or academia.
• Up to date specialist level of knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products.
• Working knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
• Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
• Excellent written and verbal communication skills.
• Ability to handle high throughput of work and commensurate with experience and knowledge to meet required deadlines.

Skills

• Toxicology
• Non-clinical regulatory affairs
• Relevant legislation and procedures applicable in the licensing of human medicinal products
• Written communication
• Verbal communication
• Delivering at Pace
• Communicating & Influencing
• Managing a Quality Service

Location

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

Work Type

• Full-time
• Permanent
• Hybrid

Experience Level

• Substantial experience

About the Company

• 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 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.