Director Regulatory Affairs
Brenda leads the Regulatory Affairs team at Cinfa Biotech. This role includes strategic planning and management of regulatory procedures and interactions in the EU, the USA and other regions. Brenda led the EU marketing authorization application for Pelmeg®, the first product of Cinfa Biotech. Prior to joining Cinfa Biotech, Brenda held positions in analytical characterization of biopharmaceuticals and in regulatory CMC within the Global Regulatory Affairs department of a leading biosimilar development company. During that time, she gained experience in biosimilar development, in managing complex projects with internal and external partners, and in the preparation of biosimilar regulatory submissions destined for highly-regulated markets. Brenda holds a PhD in biology.
Cinfa Biotech S.L.