Overview

We are looking for a Non‑clinical Assessor to join our Clinical Investigations and Trials Function within the Science Research and Innovation Group of the Medicines and Healthcare products Regulatory Agency (MHRA). The position is full‑time and permanent, based at 10 South Colonnade, Canary Wharf, London, E14 4PU. Working arrangements are flexible and hybrid, with a minimum of 8 days per month on site, up to 12 days where required, and the remainder remote or in the office.

Eligibility & Work Authorization

• UK nationals, nationals of Ireland, Commonwealth countries, EU, Switzerland, Norway, Iceland, Liechtenstein and family members of those nationalities with settled or pre‑settled status, and certain other specified nationalities.
• Necessary security checks, including disclosure, barring, animal rights, pro‑life activism, and a fraud database check, are required.
• Vaccination and health surveillance may be required for laboratory‑based or overseas roles.
• Applicants must meet the Civil Service diversity, equal opportunities, and recruitment principles.

Core Responsibilities

• Carry out risk‑based assessment of data provided in clinical trial authorisation initial and amendment applications for chemical, biological or advanced therapy products, providing recommendations and decisions in line with public health protection.
• Prepare and present objective assessment reports and scientific papers to expert advisory bodies.
• Manage own workload and workload of support team and other assessors to meet agency deadlines.
• Maintain accurate data in agency, group and unit level databases.
• Develop and maintain good working relationships with internal and external stakeholders, and participate in ad‑hoc tasks and projects as required.
• Provide scientific advice to companies on non‑clinical and regulatory issues for development of new drug products.

Key Qualifications

• Degree in toxicology or another appropriate life science, with relevant postgraduate experience or PhD.
• Previous experience in regulatory affairs, toxicology, or pharmacology within academia, governmental departments or the pharmaceutical industry.
• Up to‑date specialist level of knowledge in at least one relevant scientific area, with broader knowledge of non‑clinical development of human medicinal products.
• Knowledge of relevant legislation and procedures applicable to the regulation of clinical trials.

Essential Skills and Strengths

• Managing a quality service: ability to handle throughput of work, meet deadlines, and adhere to legal and regulatory requirements.
• Delivering at pace: flexibility to adapt to changing priorities and take responsibility for outcomes.
• Effective decision making: clear communication of purpose and reasons for recommendations and decisions internally and to external experts.
• Relationship building and teamwork.

Working Arrangements and Compensation

• Annual salary: £60,778.
• Culture of flexible working, benefits, annual leave, bank holidays, and a defined benefit pension scheme.
• Additional benefits include occupational sick pay, mobility clause, interest‑free transport loans, employee assistance services, and participation in Civil Service clubs.

Application Process

Online application form – an application question of no more than 750 words demonstrating how you meet the person specification and key responsibilities as outlined in this advert. Interviews may involve behavioural, experience, technical and strengths success profiles. Successful candidates must pass the required security checks.