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Regulatory Affairs Administration & Publishing Specialist

Ref: 9221472

  • €32,000 - €34,000
  • 05 May 2020
  • Dublin (West)
  • Perm

Brightwater has been retained in the search for a Regulatory Affairs Administration and Publishing specialist to 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.

Role objective:

• 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 IT team for any queries related to eCTD management • Perform assigned tasks to the highest standard and in accordance with established internal timelines and guidelines. • Communicate any change in status for assigned tasks • Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times • Implement and maintain Standard Operating Procedures where relevant to the regulatory function • Implement regulatory trainings on eCTD requirements for all regulatory personnel • Ensure that the submissions are archived on the common location as per established process • Accurate records are kept and maintained in a secure manner as per Good Documentation Practice; ensure proper data management and archiving

Profile:

• Results and performance driven – deliver results that meet or exceed expectations • Accountability and ownership – deciding and initiating actions • Sense of urgency – responding to issues and opportunities in a timely manner • Intellectual curiosity – willing to suggest and try new ideas • Positive and pro-active approach to business tasks • Excellent interpersonal and communications skills. • A solutions provider with strong multi-tasking abilities • Manage evolving deadlines effectively with regular feedback and updates • Enthusiasm and Drive to take ownership and drive process initiatives.

Experience required:

• 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

Benefits:

• Highly competitive salary • Healthcare • Pension • Bonus

Visa Compliance

Due to the urgency of this vacancy, it is not possible for our client at this time to consider anyone without the appropriate work permits, visas or sponsorships already in place. Therefore, we are unable to consider candidates who do not have full authorisation to work in Ireland. Applications submitted without the necessary visa in place will not be considered. To apply for this Regulatory Affairs Administration and Publishing specialist role, click the “Apply Now” button or for more information, please contact