Charline Lays

Charline Lays is a highly experienced regulatory affairs professional with 14.3 years of work experience. She has expertise in biotechnology, clinical trials, and regulatory submissions in the pharmaceutical industry. Based in Belgium-Wallonia-Namur, Charline has provided regulatory assistance to various pharmaceutical companies, specializing in developing innovative medicinal products. She has also written investigational medical product dosagesier (IMPD) and investigator's brochures, as well as briefing documentation and providing scientific advice to national European Competent Authorities. Charline has also successfully prepared and delivered clinical trial applications and completed regulatory project plans. She has experience in setting up quality systems and has successfully set up CMC activities.