Kaluki is an accomplished certified regulatory professional serving as a Manager in Regulatory Affairs for the Cell and Gene therapy and Plasma products at Fresenius Kabi. With a scientific background in Chemistry and a regulatory career spanning multiple industries – including medical devices, cell therapies, pharmaceutical and consumer goods, she brings a broad regulatory perspective and a deep understanding of diverse regulatory frameworks. This versatility enables her to develop effective solutions to complex regulatory challenges, especially in emerging areas such as CGT. She is a contributor to the EASYGEN Consortium WP5 by providing relevant inputs into the regulatory strategies aimed at closing gaps in the CGT EU regulatory framework, specifically for automated cell therapy products.