Rola Mazloum, M. Sc., Senior Regulatory Affairs Consultant
With 18 years of experience in regulatory affairs, I collaborated with different regulatory agencies such as Health Canada, FDA, GCC, Saudi FDA, EMA, therapeutic goods administration (Australia) but with a primary focus on the U.S. FDA, and Health Canada. I successfully developed and managed regulatory strategies, submissions for pharmaceutical products (drugs) aimed at both the U.S. and Canadian regulatory agencies for drugs in development. This included managing, preparing, and submitting various regulatory filings such as INDs, IND amendments, annual reports, MedWatch reports, ODD request and ODD annual reports and CTA in Canada. Moreover, as part of my Canadian experience I also managed, prepared, and submitted NDS and supplementals to Health Canada, DINA. I also managed prepared and submitted post-approval activity submissions (NC, PDC, Annual drug notifications, L3 Changes, PM and labels updates) for marketed drugs as well as other pharmaceutical products. I even submitted DEL renewals, PLAs for natural health products, and TMA for caffeinated energy drinks.
