Pharmaceutical Quality Assessor

Government Recruitment Service; Borough of Runnymede; On-site; GBP 40,000 - 50,000; Full time

Job summary

A governmental agency in the UK is seeking an experienced professional to join their Quality team in the Veterinary Medicines Directorate. This role involves assessing quality data for veterinary medicine authorisations and ensuring compliance with regulatory standards. The successful applicant will evaluate pharmaceutical data, collaborate with internal teams, and maintain current knowledge of the field. Ideal candidates will have a relevant degree and be skilled in scientific assessment and communication, with opportunities for junior assessor management and contributions to international strategies.

Qualifications

• Experience in assessing applications for marketing authorisations for veterinary medicines.
• Strong background in regulatory science and guidelines.
• Ability to manage and develop junior assessors, though not a primary duty.

Responsibilities

• Assess pharmaceutical data according to legislative timelines.
• Evaluate data quality and make recommendations.
• Communicate assessments to decision-making groups.
• Support junior assessors and contribute to team development.

Skills

Assessment of chemistry and pharmaceutical data

Scientific analysis

Written communication

Collaboration

Knowledge of ISO standards

Education

Relevant degree in pharmaceutical sciences or a related field

Job description

About the VMD

You may not have heard of the Veterinary Medicines Directorate (VMD), but have you ever:

• eaten meat, eggs, fish or honey
• drunk milk
• owned a pet or animal
• taken antibiotics

If you said yes to any of the above, you are directly affected by what the VMD does.

The VMD is the regulatory and policy lead responsible for issues concerning the authorisation, use, and manufacture of veterinary medicines in the UK.

Our aim is to protect public health, animal health, and the environment, and promote animal welfare by assuring the safety, quality and effectiveness of veterinary medicines.

Find out more at: About us - Veterinary Medicines Directorate - GOV.UK

About the Job

This exciting and interesting job puts you at the heart of authorising veterinary medicines for the UK market and plays a major role in assuring the quality and hence the safety and efficacy of these medicines. You will be a member of the Quality team, one of three specialist teams within the Pharmaceuticals Section, which is in turn part of the Authorisations Division.

The main role of the Quality team is to assess quality data submitted by companies in support of their application for marketing authorisations for veterinary medicines, and applications to vary these authorisations. The Quality team also has a significant role in the delivery of the VMD's regulatory science strategy, development of regulatory and scientific guidelines, assessment of product defects, and supporting delivery of the VMD's international activities, including training other veterinary medicines regulators.

You will be responsible for:

• The assessment of chemistry and pharmaceutical data for applications for:
  • new marketing authorisations for pharmaceutical veterinary medicines.
  • variations to existing marketing authorisations.
  • quality aspects of animal test certificates (ATCs) to conduct clinical field trials.
• Collaborating with members of the Authorisations Division to achieve the Division’s overall objectives.

Your main duties will be to:

• Scientifically assess pharmaceutical data submitted by companies in support of their applications in line with legislative timelines and relevant guidance documents. These applications may encompass new marketing authorisations, ATCs, as well as variations to current marketing authorisations.
• Undertake a detailed evaluation of pharmaceutical data and, in liaison with other assessors, formulate a recommendation to accept or refuse the application, based on the benefits and risks you identify during the assessment.
• Produce a written report that forms the quality section of the overall VMD assessment report for the application.
• Peer review assessment reports prepared by other quality assessors.
• Communicate your assessments clearly to internal decision‑making groups – to enable them to decide whether the data satisfy regulatory requirements and to decide on a course of action.
• Advise applicants on technical aspects of potential and ongoing applications.
• Deal with enquiries and represent the quality team at meetings with internal and external stakeholders.
• Maintain and develop a thorough working knowledge of own specialism.
• Maintain awareness of current developments, legislation and guidance affecting pharmaceutical veterinary medicines within National and International context.
• Contribute to the production of relevant training materials in order to pass on knowledge to other members of the VMD, as well as external clients.
• Comply with ISO 9001 (quality management) and ISO 27001 (information security) standards, and GDPR and record management requirements.
• Act corporately – meeting, role‑modeling, embedding, and championing the corporate objectives set by the VMD.

Though these are not part of your main duties, we may also ask you to:

• Manage and develop junior assessors in the team.
• Contribute to development and revision of industry guidelines.
• Contribute to the delivery of the VMD International Strategy (which may involve foreign travel).
• Contribute to the VMD Regulatory Science Strategy.
• Contribute to the VMD R&D programme.
• Contribute to the establishment of enhanced external regulatory and scientific networks.