Ramūnė Rūkienė – MSc

Ramune Rukiene joined Biomapas as Director of Regulatory Affairs to further strengthen the continued growth and geographic extension of Biomapas. Ramune graduated from Vilnius University with a speciality in Microbiology. Since 1999, she works in the regulatory affairs area. Ramune Rukienė is a regulatory professional with 20 years of experience in the regulation of biosimilars and biologics. Before joining Biomapas, Ramune was working in Teva as Global Regulatory Lead for biosimilar drug product and Global CMC Regulatory Lead for another biological product. Along with these activities, Ramune was Head of Regulatory Affairs at Sicor Biotech Vilnius manufacturing site for biotech products, where she supported manufacturing operations with regulatory supervision and was developing a strategy for CMC submissions. Moreover, Ramune has 10 years of experience working in R&D in the area of biotechnology, leading biosynthesis of rDNA technology-based protein products. Her professional expertise extends to leading MAAs in the EU, Japan, Australia, Canada and the US.