Regulatory Affairs Officer Pd&Ra
Eindhoven En Omgeving, Nederland
The work at Dechra involves all activities related to world-wide registration of products produced by Dechra. The coordination of European MR, DCP and National procedures, contact with authorities in all concerned states, answering questions and in generla trouble shooting during the whole registration procedure. Also occasionally the writing of the summary of product characteristics, the toxicity file, the residue file and the file on preclinical and clinical data and the corresponding expert reports.• Writing outlines, protocols and study reports for (pre)clinical trials on residues, tolerance and efficacy and the monitoring of these trials; submitting the final registration files and answering questions of the authorities.The products that are registered by Dechra are subsequently marketed in the Netherlands and Belgium and in approximately 40 other countries in Europe, Africa, Canada, South America, the Middle East and Far East.