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Regulatory Affairs Officer
Walker Cole Internationalbarcelona, EspañaHace más de 30 días
Descripción del trabajoExperience in authoring and reviewing dossiers Proven Regulatory experience and post-approval MA maintenance (including both product labelling and CMC activities) Knowledge of ICH Understanding the basic principles of Regulatory Affairs Good communication skills and work well within a team Spanish and English language
Walker Cole is searching for a Regulatory Affairs Officer for an exciting novel biologics pharmaceutical business in Spain. This is an opportunity for an enthusiastic and ready to learn professional who is looking to expand their scope in Regulatory Affairs.
Your responsibilities of a Regulatory Affairs Officer :
- Prepare and compile regulatory submissions for medicinal products in EU and ROW
- Prepare high quality CMC documents
- Review Artwork and promotional materials
- Provide Regulatory guidance, advice and input into regulatory submission strategies for new and established products
- Communicate with Regulatory agencies
A Regulatory Affairs Officer will have :
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Regulatory • barcelona, España