CMC Document Coordinator

5 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €65,432 - €123,456
Regulatory Specialist Role

Support the completion of Module 1 CMC-related information for regulatory submissions by preparing and setting up CMC documents in a regulatory information management system.

Key Responsibilities:
  • Develop global submission strategies incorporating information management expertise and country-specific knowledge.
  • Coordinate global registration activities, prepare necessary documentation, and communicate with international teams.
  • Update CMC CTD content consistently with approved manufacturing changes.
  • Adhere to document naming conventions and classification requirements.
Requirements:
  • Bachelor's Degree in a scientific or health sciences discipline.
  • Prior experience in pharmaceutical drug development or a related industry is beneficial.

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