Dr. Anu Gaur is a Senior-Level US & Global Regulatory Affairs Strategist Leader, and a Teaching Faculty member in the Regulatory Affairs Graduate Program at Northeastern University. An accomplished PhD Scientist, with several years of Academic Teaching & Life Sciences/Healthcare industry experience. Dr. Gaur has worked in the US & Global Regulatory Affairs for Medical Devices (Class I, II, III manufacturing environments), & Pharmaceuticals/ Biotechnology (Therapeutics), comprising over 16+ years of commercial industry experience. Dr. Gaur has demonstrated excellent leadership in Life Sciences (Therapeutics), & Medical Devices/ Technology products, their Life Cycle Management (LCM), including Pre & Post-Market Regulatory Compliance. Dr. Gaur is a versatile Regulatory Affairs Expert demonstrating contributions in leading communications, strategies, and negotiations for regulatory submissions processes and their market approvals interacting with the US FDA, EU, Canada, Japan, Latin America (LATAM), Asia-Pacific (APAC) and ROW Global Regulatory Agencies, including both regulated & non-regulated (& Islandic regions) constituting 80+ global markets globally.