Job Details: Regulatory Affairs Administrator - eCTD


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Regulatory Affairs Administrator - eCTD
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 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

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