Regulatory Affairs & Translation Officer
Since beginning of 2005 I am part of the team.
As master in translation I am responsible for a first revision of the translations: correct standard terms, MedDRA terminology? We regularly widen our translator network and I take care of the screening of possible future translators.
As RA Officer, I assist Noëlla Heyman as to the submission of registration files, renewals and variations as well as adjustments to SmPCs and PILs. I am also responsible for the follow-up of these files. Since these files have to be submitted electronically – ‘e-submission’-, according to some strict rules, quite some preparation precedes to this. I do my best to keep up the changes in these rules. Our target is ‘zero-tolerance’!
Little by little I also find my way in pharmaco- and materiovigilance.