Mandeep Khurana

International Regulatory Affairs Senior Associate @Gilead Sciences

Health Authority (EMA) contact for multiple products. Responsible for preparing complex regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures. • Provide input to the content of the original label. • Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories. • Initiated and contributed to local process improvements, which have a significant impact on the working of the Regulatory Affairs function and other departments. • Participated in and lead various group meetings and presents project status updates and strategic approaches to complex programs/projects. • Department lead for Label Change Tracking system • Health authority inspection SME for Label Change tracking system