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Regulatory Affairs Specialist

2 months ago

Reading, Reading, United Kingdom Caresoft Global Limited Full time

Job Title: Regulatory Life Cycle Management Scientist

Employment Type: Contract

Salary: Competitive

Job Summary:

Caresoft Global Limited is seeking a highly skilled Regulatory Life Cycle Management Scientist to join our team. As a key member of our Global Regulatory Affairs Life Cycle Management Team, you will be responsible for building medicinal product capability and ensuring regulatory aspects are well reflected in projects, work processes, and systems.

Key Responsibilities:

  • Build medicinal product capability within Regulatory Affairs Life Cycle Management
  • Ensure medicinal aspects are well reflected in projects, work processes, and systems
  • Deliver to time and to GPS SOPs on agreed and aligned priority base business projects across each franchise and region
  • Coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe
  • Coordinate with Local Regulatory Affairs for variations, renewals, and answering health authority requests
  • Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance
  • Advise organization of potential regulatory risks in normal day-to-day activities and recommend compliant actions
  • Ensure regulatory assessments are conducted for change controls in the respective Veeva Quality Tracking System
  • Ensure that the Veeva Regulatory Information Management System is maintained and updated for all activities under role responsibility
  • Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches
  • Contribute to new regulatory policies, systems, and processes to reinforce governance and compliance across LCM and the Regulatory Affairs function

Requirements:

  • Master's Degree in pharmacy, engineering, chemistry with knowledge in Regulatory Affairs
  • Proficiency in English
  • Ability to work permanently in country of residence
  • Strong motivation for Dossier Maintenance and Product Change Management
  • Skilled in working with complex Regulatory databases
  • Strong initiative and follow-through with accountability for work quality

About Us:

Caresoft Global Limited is an independent highly-experienced recruitment consultancy dedicated to specialist markets within the Automotive, Aerospace, Agricultural & Construction Industries.