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Regulatory Affairs Specialist

2 months ago

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

Job Summary

The Medicines and Healthcare Products Regulatory Agency is seeking a highly skilled Regulatory Affairs Specialist to join its Innovative Medicines Function within the Healthcare Quality and Access group.

This is a full-time opportunity, on a permanent basis. The role will be based in a dynamic and collaborative environment, where the successful candidate will have the opportunity to work with a talented team of professionals.

The Agency is committed to enhancing and improving the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The Healthcare Quality and Access portfolio aims to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access, including accelerated access pathways.

The Innovative Medicines function delivers a risk-appropriate critical appraisal of quality, safety, and efficacy of innovative medicinal products, determining whether a product's benefits outweigh the risks.

Key Responsibilities

  • Assess the pre-clinical aspects of marketing authorisation and clinical trial applications for medicinal products and take decisions on their suitability for approval.
  • Carry out the assessment of data provided in marketing authorisation applications and clinical trial authorisations for chemical and biological products, making appropriate recommendations and decisions in line with the protection of public health.
  • Manage own workload, working in conjunction with service coordinators and other assessors to meet agency deadlines.
  • Prepare and present objective assessments or other scientific papers to expert advisory bodies.
  • Display a high level of attention to detail to ensure up-to-date, accurate data and documents are held on internal databases.

Requirements

  • Degree in toxicology or other appropriate life science.
  • Previous experience in one of the following: toxicology or non-clinical regulatory affairs, within the pharmaceutical industry, governmental departments, or academia.
  • Up-to-date specialist-level 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

  • Salary: £56,353.
  • Contributions towards membership of the Civil Service Defined Benefit Pension scheme.
  • Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff.
  • Privilege Leave: 1 day.
  • Hours of Work: 37 hours (net) per week for full-time staff in all geographical locations, including London, and pro-rata for part-time staff.
  • Occupational Sick Pay (OSP): 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.