Independent consultancy with office throughout Europe who deliver a highly professional service to the Pharmaceutical industry encompassing Regulatory Affairs, PVG, Health Economic Evaluation and QA.
They have a requirement for a Regulatory Affairs eCTD publishing specialist, the position can accommodate some home working but will be mainly office based at my clients offices in Surrey therefore I cannot accept applications from candidates who cannot commute to Surrey.
Suitable Candidates will have experience in the following,
-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).
A full job description is available on application.
Kind regards
Paul Duffy
Manager ~ Contracts Division
Specialist Contract Pharmaceutical Recruitment
+44 (0) 1293 77 66 44
paul@barringtonjames.com
Click Here for www.barringtonjames.com
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