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Regulatory Affairs Specialist

2 months ago

Reading, Reading, United Kingdom CK Group Full time

Job Opportunity:

CK Group is seeking a highly skilled Regulatory Life Cycle Management Scientist to join their team on a contract basis for 12 months.

About the Company:

Our client is a leading global consumer healthcare business with well-established household brands.

Job Summary:

The successful candidate will be responsible for coordinating Regulatory Life Cycle Management activities across multiple countries, both within and outside Europe.

Key Responsibilities:

  • Coordinate with Local Regulatory Affairs teams for variations, renewals, and responding to health authority requests.
  • Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve variations for the specific product portfolio.
  • 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, including review of documents.
  • Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches.
  • Requirements:
    • Educated to a Master's degree level in pharmacy, engineering, chemistry, or a similar field.
    • Regulatory affairs experience in OTC medicinal products and experience of lifecycle management across EU or wider markets.
    • Experience of dossier maintenance and product change management as well as working with complex Regulatory databases.