Name: Mary Ann smith
Company: Advanced Cell Diagnostics - a Bio-Techne Company
Job title: director Senior, Seguridad, GarantÃa de Calidad y Asuntos Regulatorios
Country of Residence: United States
Precise location: San Francisco Bay Area
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More Informations About This Profile (Education, Experience, Skills, etc...)
Education & Professional Experience
Mary has studied at University of California, San Francisco between 2010 and 2012, then at in Technology Management between 1996 and 1998, then at in Pharmacy between 1987 and 1992.
Mary worked for Advanced Cell Diagnostics - a Bio-Techne Company as Senior Director, Safety, Quality Assurance and Regulatory Affairs between Jun 2018 and Jan 2020, for Novartis as Director Regulatory Policy, Digital Medicines and Medical Devices between Jan 2009 and Jun 2018, for IPAC RS as Board Member between 2007 and 2015, for Nektar Therapeutics (formerly Inhale Therapeutic Systems Inc.) as Associate Director Regulatory Affairs between Jun 2005 and Dec 2008, for Hitachi Chemical Diagnostics as Director Quality Assurance & Regulatory Affairs between 2000 and 2005, for Brand Institute as Director Buisness Development between 1999 and 2000, for Stanford Research Institute as Market Analyst - Oncology between 1998 and 1999, for Abbott Laboratories as Various Quality & Compliance between 1992 and 1998.
Skills & Competences
Mary has the following skills : Pharmaceutics, Drug Development, Combination Products, Biotechnology, Clinical Development, Medical Devices, Due Diligence, Clinical Trials, Quality System, IND, Auditing, Biopharmaceuticals, Biologics, Strategy, GxP, IVD, Regulatory Submissions, FDA, Regulatory Strategy, Regulatory Requirements.
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