Jobs at Medicines and Healthcare products Regulatory Agency

Lead and implement communications strategies for the Business Technology Change programme. Develop integrated plans, advise senior leaders, manage multi-channel delivery, create messaging, engagement and briefing materials, and map and engage stakeholders to support organisational priorities.

Review and validate regulatory submissions for medicines, apply UK/EU legislation and guidelines, prepare case folders or validate application validity, ensure data quality and consistency, follow SOPs, meet targets, liaise with applicants and colleagues, and support DAQ operational processes and improvement activities.

Assess the quality aspects of initial and variation marketing authorisation applications for biological medicinal products. Provide scientific and regulatory advice, prepare risk-based assessments and presentations, manage workload to meet deadlines, maintain accurate records, contribute to guidance development, and engage with internal and external stakeholders to support safe patient access to unlicensed and licensed medicines.

Lead regulatory work on diagnostics within the Innovative Devices function, develop and implement the future medical devices regulatory framework, provide scientific and policy input, oversee the IVD roadmap, lead a small team, and engage with UK and international stakeholders to deliver guidance and regulatory advice.