Coming from the generic business, I have many years of experience with working in the pharmaceutical industry for human medicines. Within Regulatory Affairs I have worked with European submissions via centralised and decentralised procedures, and on regular returning occurrence also with mutual recognition procedures.
My tasks varied from preparing, composing and submitting initial MA applications to post approval applications such as variations, renewals and notifications. Preparing, composing and submitting the responses for the aforementioned applications was also part of my responsibilities.
All of the above was mostly applicable to Module 1, but I also know how to find my way in the other Modules of the dossier.
I am looking forward to being part of the enthousiastic STARoDub team and to be able to contribute to future results and successes.