Regulatory Affairs Specialist

3 weeks ago


Leicester, Leicester, United Kingdom SKC Recruitment Ltd Full time
Junior Regulatory Affairs Officer

Our client, a leading pharmaceutical organization, is seeking a highly motivated and detail-oriented Junior Regulatory Affairs Officer to support their team in ensuring compliance with regulatory requirements and maintaining high standards in Quality and Regulatory strategies.

Key Responsibilities:
  • Maintain licenses within the Quality Management System, ensuring seamless integration with regulatory processes.
  • Stay updated on training, processes, and regulations, applying expertise to identify and mitigate regulatory risks.
  • Support the Regulatory Affairs Lead and Senior Specialists in implementing Quality and Regulatory strategies, adhering to MHRA guidelines.
  • Collaborate with the Pharmagen Production and Quality Departments to ensure alignment with regulatory requirements.
Requirements:
  • Experience in Regulatory Affairs and Parallel Trade, with a deep understanding of the pharmaceutical industry and its products.
  • Expertise in Quality Management Systems, Deviations, Change Controls, Risk Assessments, Validations, and MHRA Systems.
  • Flexible, creative, and a problem solver with analytical abilities, proficient in Excel, data analysis, and decision-making tools.
About the Role:

This is a remote opportunity within a growing pharmaceutical organization, offering a chance to work with a dynamic team and contribute to the development of regulatory strategies.



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