eCTD Publishing Specialist (Contract/Freelance) - Regulatory Affairs - UK South/South East - Negotiable daily rate.

One of the client is looking for a talented individual to join their exisitng successful team on a contract/freelance agreement. The role is a pivitol part of the team. Please see an outline of the role below or look at our website - www.morganprestwich.com

Person Spec:

•Experience with NEES, eCTD and Paper Submissions
•Knowledge of European procedures (Centralised, Decentralised and Mutual Recognition)
•Good written and communication skills
•Use of docuBridge or similar publishing tool
•A confident user of MS Office, Adobe Acrobat and ISI Toolbox (Preferable)
•General understanding of regulatory affairs

RESPONSIBILITIES

•Maintain well established infrastructure for electronic submissions and eCTD.
•Make sure that the published regulatory submission is in accordance with the relevant guidelines ICH M2 (eCTD Specification), ICH M4 (Q, E, S, Organisation CTD), EU Module 1 Specification etc.) and contains all necessary navigation tools like bookmarks and hyperlinks which provide essential navigational aids for the reviewer.
•Communicate with regulatory agencies (EMA, local competent authorities) with respect to electronic regulatory submissions, answer technical queries, resolve technical issues (with relevant IT support).
•Responsible for the preparation of the same eCTD submissions for planned MAAs (e.g. Computer Validation testing by EMA).


To apply

Please send your CV to Greg Bell - greg.bell@morganprestwich.com or call me on 01737 22 66 44 to discuss this and othe positions further.