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Regulatory Case Manager Job Description

We are seeking a skilled and experienced professional to lead a small team within the Veterinary Sciences department. The ideal candidate will be responsible for managing high-volume regulatory applications, overseeing key projects, and ensuring operational excellence in a fast-paced environment.

Main Responsibilities:

  • Lead and develop your team to achieve their full potential.
  • Manage regulatory applications, including variations, new applications, transfers, scientific advice, and SPC harmonisation.
  • Act as Subject Matter Expert for projects and systems.
  • Monitor progress, ensure deadlines, and maintain quality standards.
  • Produce reports and performance metrics to inform business decisions.
  • Drive process improvements and uphold compliance standards.
  • Represent the organisation at meetings and conferences.

Required Skills and Qualifications:

  • Relevant office or administration experience with a focus on regulatory affairs.
  • Proven people management and leadership skills, with experience of leading a team.
  • Strong planning, organisational, and communication abilities, with a proven track record of delivering results.
  • Experience handling diverse, high-volume workloads, with a focus on prioritisation and time management.
  • Confidence with workflow and IT systems, including performance reporting.
  • Analytical mindset and problem-solving skills, with experience of driving process improvements.
  • Self-starter with the ability to work independently, with a flexible approach to working hours.

Nice to Have:

  • Knowledge of national and EU veterinary regulatory procedures.
  • Experience in veterinary medicinal product licensing.
  • Project management skills, with experience of delivering complex projects.
  • Lean Six Sigma or Continuous Improvement knowledge, with experience of implementing process improvements.