Regulatory Documentation Specialist

Job Title: Regulatory Documentation Specialist
Contract Type: Contract
REF: 122997
Contact Name: Gerry Kennedy
Contact Email:
Job Published: almost 5 years ago

Job Description

Regulatory Documentation Specialist (Dublin)

This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.

Job Spec

This contract regulatory-CMC role in an excellent opportunity to work for an Irish based biotechnology company that is in rapid growth and expanding its regulatory affairs team. The company produces a range of innovative products to treat a variety of health conditions.

Reporting 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, your key duties and responsibilities will include:

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.

Person Spec

The Documentation specialist will ideally have a science qualification at certificate or diploma level and/or 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.
Knowledge or experience in regulatory affairs publishing and working knowledge of CTD structure and or CTA experience would be a distinct advantage.
The Documentation Specialist will have excellent Microsoft Office skills and an ability to work independently across different departments.
Strong attention to detail and strong organizational skills.

Cv to 01 2302400