- Familiar with current European and ICH regulatory guidelines and
submission requirements/formats;
- Experience in project management;
- Product registration, variations, renewals, follow-up of the dossier
with the healthcare agencies;
- Preparation and review of Product Information, scientific information
for professionals (SmPC), patient information (PIL) and labelling;
- Regulatory Affairs follow-up, coordination and support for files at a
worldwide level;
- Familiar with CPP;
- Solid background in OTC, RX products and generics as well;
- Quality Assurance, coordination of
batch releases (QP);
- Cosmetics: formulation and packaging review, preparation of Notification
and Authorities Submission.
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