Regulatory Medical Expert

1 week ago

London, Greater London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time
Job Summary

We are seeking a highly skilled Regulatory Medical Expert to join our team at the Medicines and Healthcare Products Regulatory Agency. This is a challenging opportunity to work on the assessment of medicinal products and provide scientific and regulatory advice to companies.

Key Responsibilities
  • Lead the assessment of marketing authorisation applications, paediatric investigation plans, and waivers, ensuring that they meet the required regulatory standards.
  • Provide scientific and regulatory advice to companies, reflecting contemporary regulatory guidance and relevant regulatory decisions.
  • Prepare and present objective assessments and scientific papers at expert advisory groups and Commission on Human Medicines as needed.
  • Manage own workload and work collaboratively with other assessors to meet agreed timelines and respond to public health demands.
Requirements
  • Degree in Medicine and relevant postgraduate qualification. Registered to practice clinical medicine.
  • Extensive regulatory experience and understanding of UK and international regulation, as well as professional or scientific expertise in their discipline.
  • Proven ability to work independently and effectively to evaluate and provide insight into complex assessments, using evidence from multiple sources to make appropriate recommendations or decisions.
  • Knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
Benefits
  • Salary of £76,000, plus contributions towards the Civil Service Defined Benefit Pension scheme.
  • 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days, plus 8 bank holidays.
  • Flexible working to ensure a healthy work-life balance.
  • Interest-free season ticket loan or bike loan.
  • Employee Assistance Services and access to the Civil Service Benevolent Fund.

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