Regulatory Affairs Specialist
Hikma Pharmaceuticals
مجموع سنوات الخبرة :16 years, 10 أشهر
-Implement and execute on goals, strategies and policies developed by Executive Team
-Execute and maintain regulatory activities for both new and approved drugs including filings, labeling, advertising and promotional review
-Monitor and ensure compliance with regulatory expectations of the U.S. FDA regarding quality and timing of submissions
-Review, finalize and approve all regulatory fillings prepared by local U.S. Regulatory Teams for both new and approved drugs
-Handling the preparation and maintenance of regulatory affairs database
-Supervising the takeover of all acquired existing NDA/ANDA documentation as per U.S. FDA expectations
-Prepare periodic reports with respect to the function’s activities and achievements related to US market
-Preparation and submission of ANDA, Amendments (Bioequivalence amendments, CMC amendments, Labeling amendments…etc.), supplements (Prior approval supplements, CBE-30 Days Supplement and CBE-0 Day Supplement) and Annual reports
-Communication with the regulatory agency
-Evaluation of Any changes for the approved and pending products
-Review and approve the test methods, specifications, stability and packaging standard for raw materials, in-process materials and finished product materials of the ANDA
-Initiation or revising the labeling materials (inserts, medication guide, bulk labels and container labels)
-Keep updated with the latest changes of the guidelines
-Drug listing for U.S. products
-Follow up with all batches placed into stability and validated because of the regulatory requirements
-Undertaking and managing regulatory inspection
-Advising and dealing with any related questions or complaint regarding the regulatory requirements
-Professional using and Calibration of HPLC (Shimadzu, Dionex & Thermo TSB), UV spectrophotometer, Dissolution, Karl Fischer and Differential scanning Calorimetry (DSC) instruments
pplying and using different Pharmacopoeias (USP, BP and EP)
-Analysis of raw materials and Finished products samples
-Develop and validate methods of analysis
-Conducts literature search for the projects including publications, patents, etc.
-Designs and conducts pre-formulation, formulation development and scale-up manufacturing on assigned projects
-Conduct stability studies
Research Topic: Stability and Solubility of Amorphous Ezetimibe in solid Dispersions. During my search, which was a collaborative work between JUST and Lulea University in Sweden, I was able to experience different instruments which include Differential scanning Calorimetry, Powder X-Ray Diffraction and Fourier Transform-Infrared Spectroscopy.
