Collaborating with the coordination and monitoring of the required documentation:

• Attending the projects meetings for collaborating with the coordination of the internal activities related to the CMC (DS-Drug Substance and DP-Drug Product) at development stage, registration and commercial stage (LCM)
• Selection of alternative sources for FDFs and API: Managing/handling of documentation (Legal and Quality)
• Product guard: Collaborating in the activities related to the project management along with the Quality and CMO Management dept., with the designing of the documentation management system, as well as with the documentation management itself (Technical, Legal and Quality wise)

Contribution:

•  Managing/handling and negotiating a specific and reduced CMOs portfolio through annual forecasts, contracts review, as well as initiating and participating in the screening, tenders and awarding of contracts during the introduction of new sources (FDFs and APIs)
• Collecting the information (know-how, technical, quality and regulatory requirements, etc) of FDFs and APIs for the projects related to the pharma portfolio, either at commercial or development stage, in order to align in a correct manner the CMC’s activities with the targets of the Esteve’s R&D projects
• Collaborating with CMO Management and Quality team in obtaining the information generated by the CMOs, in a way that the same meets the regulatory requirements of key territories during the commercial and development stage of Esteve’s products
• Assuring the harmonization of the Pharma Management (systems and business wise) with the rest of the Esteve Group, through the cooperation and participation, matrix wise, with the Global Direct Procurement Compliance and Regulatory Manager