Anu is a Senior-Level US & Global Regulatory Affairs Strategist Leader, and a Teaching Faculty in the Regulatory Affairs Graduate Program at Northeastern University, Boston. An accomplished PhD Scientist, with Academia & Life Sciences industry experience. Anu 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. Anu has demonstrated excellent leadership in Life Sciences (Therapeutics), & Medical Devices/ Technology products, their Life Cycle Management (LCM), including Pre & Post-Market Regulatory Compliance. Anu 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. Anu has earned the Regulatory Affairs Certification (RAC) for United States (RAC-US) and Global (RAC-Global) designation. Anu is an active member of Regulatory Affairs Professional Society (RAPS) contributing as an Engaged member, Champion, Ambassador, Subject Matter Expert (SME), and a Contributing Author. Anu is an Ambassador for WEST (Women in the Enterprise of Science & Technology), and has maintained professional memberships at Healthcare Businesswomen’s Association (HBA), American Chemical Society (ACS), and Association of Clinical Research Professionals (ACRP) associations. Anu is a volunteer for the United Nations of Greater Boston, and UNICEF UNITE Boston Chapter. Education Highlights: • PhD (Chemistry), Masters (Chemistry), Bachelors (Biology) • Executive MBA (Global Strategy & International Business) - MBA Residencies (Wash DC, France, Czech Republic, Switzerland, Mexico)