Regulatory Life Cycle Management Specialist

6 days ago


Reading, Reading, United Kingdom CK Group Full time

CK Group is seeking a highly skilled Regulatory Life Cycle Management Specialist to join a global Consumer Healthcare company on a contract basis for 12 months.

Company Overview:

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

Job Summary:

The successful candidate will be responsible for coordinating Regulatory Life Cycle Management activities across multiple countries within and outside Europe. This will involve working closely with Local Regulatory Affairs teams to ensure compliance with regulatory requirements.

Key Responsibilities:

  • Coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe.
  • Work with Local Regulatory Affairs teams to ensure compliance with regulatory requirements.
  • Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance.
  • 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.

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.


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