eCTD Administrator and Publishing Specialist

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Job Description

On behalf of my client, a global pharmaceutical company based in Dublin, I am recruiting for an eCTD Administrator and Publishing Specialist to join their team.

Job 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
Convert submission pack received from Regulatory Officer to eCTD compliant document
Bookmark and hyperlink documents as per specifications
Compile PDF documents into eCTD-formatted submissions
Request eCTD applications numbers, as required from regulatory Health Authorities
Validate eCTD applications according to specifications
Submit of applications and sequences through the Electronic Submission Gateway
Track document publishing progress for electronic submissions by using tracking tools and inform Regulatory Officer of the submissions date and successful validation dates
Forward any queries received from Health Authorities to the relevant Regulatory Officer
Identify and obtain any deficient information in order to complete the compilation within the allocated time frame
Proactively inform Regulatory Officer and other involved business units regarding all identified risks related to the planned eCTD submission
Keep RA submission team updated on eCTD requirements
Use eCTD system in accordance with the company internal procedures and in lines with assigned roles and permissions
Liaise with eCTD software provider and companys IT team for any queries related to eCTD management
Communicate any change in status for assigned tasks
Implement regulatory trainings on eCTD requirements for all regulatory personnel
Accurate records are kept and maintained in a secure manner as per Good Documentation Practice; ensure proper data management and archiving

Minimum requirements
High level education in Life sciences or related area
At least 2-3 years in a similar role in Regulatory department in the pharmaceutical industry
Experience with eCTD software

For more information and to apply for this role please call Zoe on +353 1 2784671 or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671

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  • Salary:Negotiable
  • Location:Dublin City Centre
  • Type:Permanent
  • Category:Science,Thornshaw