Saskia van Brenk
I am a quality driven Regulatory Affairs CMC specialist, educated as a Pharmaceutical Engineer with a B.Sc. degree in Chemical Engineering. Since 2005, I have gained experience with various aspects of the pharmaceutical industry. During my career I have been involved in product/process development, stability testing (strategy), process optimization, change control, process performance qualification/process validation for pharmaceutical products, medical devices and combination products. Working in Regulatory Affairs I supported complex site transfer projects with world-wide regulatory impact related to small molecule drug substance and drug product, as well as BLA/MAA dossier preparation for biological medicines and vaccines. With my technical background, regulatory knowledge and good eye for detail I’m a respected team member of multidisciplinary and international project teams. I enjoy working for Starodub because of the variety of projects and the team’s spirit. The team is ‘eager to win’ and aspires to be the ‘best in class’.