Tasnim Sherif Shaaban

Regulatory Affairs SpecialistFull Time

• Job Details:•Responsible for products’ registration & re-registration at Central Administration for Pharmaceuticals Affairs (CAPA), National Organization for Drug Control and Research (NODACR), and National Organization for Research and Control of Biologicals (NORCB). •Prepare and organize products’ folders according to ministerial decrees to be sent to CAPA, NODCAR, and NORCB. •Revise all data received from R&D department including composition, specification, method of analysis, and validation protocol. •Prepare Common Technical Document (CTD) file for under-license products.