Merck
Associate Director Regulatory Affairs
Ophthotech Jun 2016 - Dec 2016
Regulatory Cmc Consultant
Kyowa Hakko Kirin Co., Ltd. Jul 2015 - Jun 2016
Regulatory Cmc Consultant
Gsk May 2013 - May 2015
Biopharm Regulatory Cmc Manager
Bristol-Myers Squibb Jul 2007 - May 2013
Regulatory Manager, Cmc
Education:
Temple University 2002 - 2007
Master of Science, Masters
Temple University Aug 2006
Master of Science, Masters
Temple University 1994 - 1996
Bachelors, Bachelor of Science, Biochemistry
Kiev Polytechnic College 1986
Skills:
Regulatory Submissions Regulatory Requirements Pharmaceutical Industry Regulatory Affairs Fda Clinical Development Ind Ectd Drug Development Oncology Quality Assurance Biopharmaceuticals Sop Cmc Regulatory Affairs Standard Operating Procedure Validation Stability Studies Analytical Skills Stability Testing Biotechnology Clinical Trials Technology Transfer Life Sciences Gmp Cmc Development Pharmaceutics Biotech