Niraj Ramachandran, PhD, is a seasoned professional in global regulatory affairs, specializing in Chemistry, Manufacturing, and Controls (CMC) for cell and gene therapies. Currently serving as the Senior Director of Technical Regulatory Cell & Gene Therapies at Genentech, they possess extensive experience in developing and executing CMC regulatory strategies, having previously held leadership positions at Platelet BioGenesis, Takeda, and Semma Therapeutics. With a PhD in Biomedical/Medical Engineering from the University of South Florida, Niraj has consistently demonstrated the ability to navigate complex regulatory landscapes and foster collaboration among cross-functional teams throughout the drug development process.
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