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

Apply Now






PDF, Word Documents only accepted

Leinster Appointments is committed to providing a professional service where all CVs are kept confidential and will not be submitted to any third parties without candidate’s knowledge or consent.
By applying, you are giving consent for Leinster Appointments to contact you about this job or similar positions.

I have read and agree with the Leinster Appointments Privacy PolicyI agree