Biomapas appoints Director Regulatory Affairs

July 2019 – Ramune Rukiene joined Biomapas as Director Regulatory Affairs to further strengthen continued growth and geographic extension of Biomapas.

With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, and Ukraine, Biomapas provides services in 60+ countries across 5 continents. As a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs, and Pharmacovigilance, Biomapas will further expand its international team and geographical coverage of its services.

Ramune will play an important role by leading regulatory activities, ensuring highest service quality and maximizing the efficiency of medicinal and veterinary product placement into the market. Furthermore, Ramune will work together with the management team to set a regulatory affairs strategy and to deliver unmatched service experience and quality in the market to Biomapas clients and partners.

“Ramune is the highest-level regulatory affairs professional globally with the focus of Biomapas values and future goals for long-term growth. Her in-depth expertise and orientation towards quality make Ramune a valuable addition to our management team. As well, Ramune gives an additional motivation to be even more dedicated to customer satisfaction and service quality in every detail, “ said Audrius Sveikata, Biomapas CEO.

Ramune Rukiene 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 EU, Japan, Australia, Canada and the US.

Clinical Trials Regulation Guide

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