Regulatory Affairs Specialist

3 days ago

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

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at the Medicines and Healthcare Products Regulatory Agency. This is a challenging opportunity to work in a dynamic environment, contributing to the regulation of medicinal products and ensuring public health protection.

About the Role

The successful candidate will be responsible for assessing pre-clinical aspects of marketing authorisation and clinical trial applications for medicinal products. This will involve reviewing data, making recommendations, and taking decisions in line with the protection of public health.

Key Responsibilities

  • Conduct thorough assessments of data provided in marketing authorisation applications and clinical trial authorisations for chemical and biological products.
  • Manage own workload, working collaboratively with service coordinators and other assessors to meet agency deadlines.
  • Prepare and present objective assessments or other scientific papers to expert advisory bodies.
  • Ensure accurate and up-to-date data and documents are held on internal databases.

Requirements

  • Degree in toxicology or other relevant life science.
  • Previous experience in toxicology or non-clinical regulatory affairs, within the pharmaceutical industry, governmental departments, or academia.
  • Up-to-date specialist knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products.
  • Knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
  • Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.

Benefits

  • Competitive salary of £56,353.
  • Contributions towards membership of the Civil Service Defined Benefit Pension scheme.
  • Annual leave: 25 days on entry, rising by one day for each completed year of service to a maximum of 30 days.
  • Privilege leave: 1 day.
  • Hours of work: 37 hours per week for full-time staff.
  • Occupational sick pay: one month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay.
  • Mobility: mobility clause in contracts allowing staff to be mobile across the Civil Service.
  • Civil Service Pension Scheme.
  • Flexible working to ensure staff maintain a healthy work-life balance.
  • Interest-free season ticket loan or bike loan.
  • Employee Assistance Services and access to the Civil Service Benevolent Fund.
  • Eligibility to join the Civil Service Motoring Association (CSMA).
  • Variety of staff and Civil Service clubs.
  • On-going learning and development.

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