Pfizer
Director, Regulatory Strategy Latin America
Pfizer Oct 2015 - Feb 2016
Senior Manager, Regulatory Strategy Latin America
Pfizer Oct 2014 - Oct 2015
Senior Manager, Labeling Strategy
Pfizer Sep 2009 - Oct 2014
Senior Manager, Worldwide Regulatory Strategy
Sandoz May 2006 - Sep 2009
Manager, Regulatory Affairs
Education:
Long Island University 2001 - 2003
Master of Science, Masters, Marketing
Stony Brook University 1996 - 1999
Bachelors, Chemistry
Ccny School of Education 1995 - 1996
Skills:
Regulatory Affairs Pharmaceutical Industry Regulatory Submissions Gmp Quality Assurance Fda Sop Regulatory Requirements Drug Development 21 Cfr Part 11 Technology Transfer Validation Change Control Strategy Anda Biotechnology Ind Pharmacovigilance Capa Chemistry Pharmaceutics Clinical Development Gcp Quality Control Cro Medical Devices Regulatory Strategy Generics Oncology Gxp Formulation Generic Programming Hplc Lifesciences Clinical Trials Computer System Validation Biopharmaceuticals Analytical Chemistry Glp Cmc V&V Lims Cgmp Vaccines