• 25+ years in Regulatory Affairs: Big pharma, mid-size, start-up and advisory. President & Principal Consultant, Drais Regulatory Consulting, LLC • Corporate pharma/biologic and medical device background designing, developing and leading global regulatory teams, including past SNI experience with SN514 • Regulatory strategy for product development / approval and geographical roll-out /post-market compliance, to include success with expedited/accelerated programs
