Regulatory Affairs professional with over 10 years of experience in the Chemistry, Manufacturing, and Controls, (CMC) environment delivering scientifically based global CMC strategies in compliance with regulatory requirements for new compounds and marketed products including a billion dollar franchise. Lead registration teams to ensure the preparation of high quality Common Technical Document (CTD) dossiers for submission in both electronic and paper to global health authorities in the US (FDA), EU, Asia Pacific, and Latin America regions and obtain rapid approvals. Experience includes facilitating health authority (US FDA, UK MHRA) meetings/negotiations for resolution of company questions and for Agency concurrence.