Regulatory Affairs & Translation Officer
Since the beginning of 2005 I am part of the infarAMA team.
As Master in Translation I am responsible for the translation department. I am the contact person in case of doubts concerning specific translation issues and quotations. We regularly widen our translator network and I take care of the screening of possible future translators.
As Regulatory Affairs Officer, I prepare, submit and do the follow-up of registration files, renewals and variations as well as adjustments to SmPCs and PILs. I share my Regulatory Affairs experience with the other Regulatory Affairs Officers and assist by giving them training and support.