After obtaining Ph.D. in biochemistry in 2013 I began my career in the pharmaceutical industry. Having a strong scientific background, I started working in preclinical drug development. Over several years I expanded my expertise to biocompatibility testing, clinical evaluations and post-market surveillance activities. I gained a broad experience in data retrieval, research methodology, developing research strategies, reviewing of medicinal products dossier and medical devices technical documentation.
For a variety of projects, I was responsible for interactions with regulatory authorities (EU and CIS national competent authorities, notified bodies, FDA) with respect to the scientific and clinical questions, including obtaining scientific advice.
Currently I have more than 10 years of combined experience with medicinal products, medical devices, food supplements and borderline products, with particular emphasis on scientific and clinical issues, regulatory intelligence and regulatory affairs.
I appreciate the opportunity to be a part of STARoDub team of experts, working on challenging projects, developing unique solutions for our clients.