Job Reference 15273
Job type
Location West Dublin
Salary € 0-40,000

The Role

Main responsibilities: 

  • Ensure timely preparation and publishing of regulatory submissions in eCTD format for EU region in accordance with relevant EU requirements and in alignment with company strategy and registration deadlines
  • Ensure proper data management and archiving
  • Convert submission pack received from Regulatory Officer to eCTD compliant document
  • Bookmark and hyperlink documents as per specifications
  • Track document publishing progress for electronic submissions by using tracking tools and inform Regulatory Officer of the submissions date and successful validation dates
  • Use eCTD system in accordance with the company internal procedures and in lines with assigned roles and permissions
  • Communicate any change in status for assigned tasks
  • Implement regulatory trainings on eCTD requirements for all regulatory personnel

The Person

Main requirements:

  • At least 2 years experience in a similar role in a Regulatory department in the pharmaceutical industry
  • Experience with eCTD software

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PDF, Word Documents only accepted

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