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Irfa******
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Spain
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Last Update: 21.01.2019 at 12:00
Job Type
Full Time
Start
ASAP
Duration
11 Month +
Place
Madrid, Madrid, Spain
Country
Spain
Category
Regulatory, Quality and Clinical
Description
Key accountabilities:
Preparing/supervising of submission of documents: Initial packages, substantial amendments and other notifications to regulatory authorities
Filling out initial application forms
Quality check of submission packages
Preparing label designs for the investigational medicinal products.
Monitoring changes on the ongoing basis in EU legislation
Advising on EU guidelines, EU requirements
Acting in compliance with EU's pharmaceutical law, ICH-GCP, EU directives and in line with local and global procedures
Ideal candidate will possess:
Several years of experience in an industry-related environment (CRO/Pharma)
Minimum of a Bachelor