Budhesh Dhamija was working in Global Regulatory Affairs department of CSL Behring GmbH in Germany since June 2018. His main responsibilities includes monitoring and assessing the European regulatory environment to anticipate and communicate regulatory trends through an understanding of regulatory guidelines, regulations, and laws that may have an impact on CSLB’s products and regulatory business processes.
Budhesh was previously employed in Novo Nordisk, Denmark within Safety Surveillance first and then transitioned to Regulatory Affairs department. Within Safety Surveillance, his main responsibilities included providing process expertise on PSUR/DSUR preparations, training and cross-project alignment of aggregate reporting. He has authored several regulatory PSURs, DSURs and clinical RMPs according to the defined development milestones or as required by Health Authorities. Additionally, Budhesh was responsible for surveillance of Novo Nordisk products during post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities as required. Within Regulatory affairs, his main responsibilities included to plan, coordinate and execute the regulatory tasks as required in the projects; including RA submission plans for activities such as variations, line extensions, PSURs, RMPs and renewals.