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 company**Apply on the
website**;s 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 **Apply on the website** 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 1
or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of
specialist Scientific Recruitment. Part of the CPL Group. Tel: 1 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 company**Apply on the
website**;s 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 **Apply on the website** 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 1
or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of
specialist Scientific Recruitment. Part of the CPL Group. Tel: 1
We need : English (Good)
Type: Permanent
Payment:
Category: Others