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

Hours
Full Time - 37 hours per week

Salary
£60,778 – £68,422 per annum plus benefits

About the Role
We are seeking a Non-Clinical Assessor (Biological) to join the Innovative Medicines Function within the Healthcare and Quality Access group. This permanent role involves evaluating pre-clinical and environmental risk aspects of marketing authorisation, Early Access to Medicines (EAMs), Innovative Licensing and Access Pathway (ILAP), and clinical trial applications for biological medicinal products. You will assess a range of new biological products including advanced therapies and innovative medicines at various development stages, considering their environmental impact. The role contributes to regulatory policy, scientific guidance, and legislative frameworks relating to innovative medicinal products and emerging technologies. Your assessments and recommendations will influence clinical trial initiation and patient access to new medicines. The position offers career development and progression opportunities aligned with internal development programmes.

Key Responsibilities
- Assess pre-clinical data for biological products in marketing authorisation and clinical trial applications, making recommendations to protect public health.
- Participate in ILAP and EAMs schemes, providing scientific advice on non-clinical and environmental aspects of drug development.
- Contribute to drafting, reviewing, and implementing legislation, scientific guidance, and policy documents.
- Manage workload effectively to meet agency deadlines.
- Prepare and present scientific assessments to expert advisory bodies.
- Support service improvement through policy and procedural development.
- Maintain accurate and up-to-date records in internal databases.
- Lead or contribute to multidisciplinary projects involving internal and external stakeholders.
- Develop skills and provide advice within the Division or Agency.
- Foster effective communication and relationships with colleagues and external stakeholders.
- Undertake other ad-hoc tasks as required.

Experience
- Previous experience in pre-clinical drug development, translational science, medicines regulation, regulatory policy, ecotoxicology, or environmental regulatory affairs within pharmaceutical industry, government, or academia.
- Experience with data analysis related to biological products; gene therapy experience is advantageous.
- Experience contributing to regulatory policy, guidance, or framework development relevant to medicinal products.
- Proven ability to work collaboratively with diverse stakeholders including government bodies, healthcare organisations, academia, industry, and patient groups.

About you
- Detail-oriented with a high level of accuracy.
- Able to manage workload and meet deadlines.
- Strong communication and interpersonal skills.
- Motivated to develop expertise in scientific and regulatory areas.
- Committed to public health and patient safety.

Qualifications
- Degree in molecular biology, toxicology, pharmacology, immunology, or a related life science discipline.