The opportunity
Work within KS Generic R&D formulation development units.
Prepare sections/files/documents for projects to be submitted in US and support in updating documentation during deficiency letters form FDA.
Work with different interfaces inside Kfar Saba R&D: pharma and analytical researchers, biopharmaceutical team, Regulatory Affairs and Quality assurance teams.
Work with different interfaces outside the Kfar Saba R&D: QC, packaging material lab, microbial lab.
Work with different Teva's R&D sites and API suppliers.
How you’ll spend your day
Prepare sections/files/documents for generic product submission for US market
Update sections/files/documents as part of deficiency letters from FDA
Prepare different protocols for submission for EU and CA markets
Prepare API/excipients monographs and update monographs for all markets according to the R&D requirements.
Work with SAP and LabWare systems
אזור מרכז - גוש דן
מלאה
פורסם לפני יותר מחודש
פורסמה ברשת