Professional Milestones
Small company acquired bigger company in Spain
When I was working in Laboratorios Aurobindo, the company acquired a bigger company called Actavis. In the RA department I had to manage all MA; changing the MAH, requesting the Withdrawal of repeated MA or changing the name for commercial reasons.
Management of a team of 5 people
When I was working in Pharmalex I had to manage a team of 5 people and guide them in very different projects. These projects included the management of new dossier submission, variations, compilation of dossiers, the management of the National Phases, the definition of the best strategy for each submission to the authorities, requestion of CPPs, performing of due diligence of dossiers, requesting MAH transfer and MA withdrawal, requesting the switch of RMS to another in a DCP and the request to the Spanish Agency for a new company to be the MAH.
Management of different projects with different companies
When I was working in Pharmalex I had to lead very different projects with very different companies accros Europe an outside Europe. So, my team and I performed SOPs/Work instructions and an Excel for each activity including the differencies in each country to do the work easier. For example, we created SOPs about how to submit a dossier in each country with the fees and specific differencies in each country. Additionally, we created an excel with all contact points for each regulatory agency by country
Approval of a different pack size than the innovative medicinal product
In my current company I received the appoval of a different pack size approved from the innovative medicinal product. I had to negotiate with the spanish authority this situation and to defend the unmet need for this medicinal product to the patient