Job Description
This is a rare opportunity to join a young exciting clinical - stage Biotechnology Company. The company produces a range of innovative products to treat a variety of health conditions.
The Regulatory Documentation Specialist will report to the Director of CMC - Regulatory Affairs, and in accordance with the goals of the company, and applicable regulations, standards, established procedures and planned objectives, as the Regulatory Documentation Specialist.
Responsibilities:
Ensuring conformance and compliance in eCTD granular sections from a technical perspective
Re-formatting source documents/templates per ICH and internal guidelines
Document Control and archivists
Assistance with regulatory and other departmental Paper and eCTD activities
The role of Documentation Specialist will involve the management of regulatory documents for submission in an electronic format to health authorities globally.
Requirements and Skills:
Bachelor's Scientist degree or relevant experience.
2-3 years' experience working in the healthcare or pharmaceutical sector managing regulated documentation requirements for submission to professional bodies or regulators through electronic and/or paper format.
You will have excellent Microsoft Office skills and an ability to work independently across different departments.
MS Office high level of proficiency especially Microsoft Word where they will be exceptionally technically competent.
Strong attention to detail and strong organisational skills.
Knowledge or experience in regulatory affairs publishing and working knowledge of CTD structure and or CTA experience would be a distinct advantage.
Travel requirements: Minimal (less than 5%) travel required.
For further information on this Regulatory Documentation Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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