Mohammed Salem, Ph.D.VICE PRESIDENT, REGULATORY AFFAIRS AND QUALITY ASSURANCE
Mohammed Salem received his Ph.D. in biochemistry from the University of Nebraska and MS from University of Michigan and completed his post-doctoral training at Scripps Hospital. Mohammed came to Apellis after spending 5 years at Fresenius Medical Care’s Global Manufacturing & Quality as Vice President, Global Regulatory Liaison for devices and drugs. Mohammed has extensive expertise in global regulatory affairs and quality assurance with over 30 years in the biotech and life science industries, including more than 20 years in regulatory and quality.
As Vice President of Regulatory Affairs & Quality at AMAG Pharmaceuticals, Mohammed led the regulatory strategies for development and approval of Feraheme®/Rienso®. Prior to AMAG, he held numerous leadership positions with increasing levels of responsibility at Sunovion (Formerly Sepracor) for approval of Lunesta®, participated in the approval of Removab® (for ovarian cancer) at Fresenius Biotech and worked in R&D at Alseres (formerly Boston Life Science), Biogen & AutoImmune.
Mohammed has global regulatory affairs experience across all stages of development with biologics, small molecules and medical devices in a variety of therapeutic areas and with a broad knowledge in rare diseases. Mohammed has led the successful submissions to expedite development programs in US, Europe and Japan such as orphan drug, fast track, breakthrough therapy, priority reviews, pediatric investigational study requirements including filings of New Drug Applications/Marketing Authorization Applications, numerous Investigational New Drug Applications and Clinical Trial Applications and has managed development and commercial regulatory activities for all drugs, biologic, medical devise and combination products.