Regulatory Affairs Specialist

2 months ago

London, United Kingdom SKC Recruitment Ltd Full time
Job Description

SKC Recruitment Ltd is seeking a highly skilled Regulatory Affairs Officer to join their team. As a key member of the organization, you will play a crucial role in supporting all aspects of Parallel Trade (PLPI), Regulatory Affairs, and Quality Management.

Key Responsibilities:
  • License Management: Submit and implement new licenses/variations promptly, ensuring compliance with regulatory requirements.
  • Collaboration and Communication: Work closely with the Regulatory Affairs Lead and Senior Specialists to ensure high standards in implementing Quality and Regulatory strategies, adhering to MHRA guidelines.
  • Quality Management: Maintain licenses within the Quality Management System, ensuring seamless production processes.
  • Regulatory Compliance: Stay updated on training, processes, and regulations, identifying and escalating regulatory risks.
  • Process Optimization: Process license applications to minimize MHRA RFIs, supporting Pharmagen Production and Quality Departments.
Requirements:
  • Experience: Proven experience in Regulatory Affairs and Parallel Trade, with a deep understanding of the pharmaceutical industry and its products.
  • Expertise: Expertise in Quality Management Systems, Deviations, Change Controls, Risk Assessments, Validations, and MHRA Systems.
  • Skills: Organized, proactive, and commercially aware, with strong communication and teamwork skills.
  • Education: Proficient in Excel, data analysis, and decision-making tools, with knowledge of patents and trademark legislations.
  • Project Management: Project management experience, with the ability to work in a remote environment.

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