Associate Director, Regulatory Affairs @ (December 2010 - January 2014)
Senior Manager, Regulatory Affairs @ (July 2007 - December 2010)
Senior Regulatory Affairs Associate @ (April 2005 - July 2007)
Manager, Quality Technical Services @ (October 1990 - April 2005)
Demeitrius Sawickij Education
Moravian University
BS (Chemistry)
Demeitrius Sawickij Skills
Regulatory Affairs
Regulatory Submissions
GMP
Regulatory Requirements
Dissolution
Validation
Analytical Chemistry
Pharmaceutical Industry
FDA
HPLC
USP
CMC
ANDA
SOP
21 CFR Part 11
Change Control
Biopharmaceuticals
Quality Control
GxP
Quality by Design
CAPA
Technology Transfer
eCTD
GLP
V&V
Quality System
Drug Development
IND
Pharmaceutics
Quality Management
In Vitro
Spectroscopy
Clinical Development
Formulation
Chromatography
U.S. Food and Drug Administration (FDA)
LIMS
NDA
Pharmacovigilance
Aseptic Processing
Computer System Validation
Cleaning Validation
Drug Delivery
Generic Programming
High-Performance Liquid Chromatography (HPLC)
Process Analytical Technology
ASTM standards
Good Manufacturing Practice (GMP)
Demeitrius Sawickij Summary
Demeitrius Sawickij, based in Coopersburg, PA, US, is currently a Vice President of Regulatory Affairs at Genus Lifesciences Inc.. Demeitrius Sawickij brings experience from previous roles at Genus Lifesciences Inc., X-GEN Pharmaceuticals, Inc. and Teva Pharmaceuticals. Demeitrius Sawickij holds a BS in Chemistry @ Moravian University. With a robust skill set that includes Regulatory Affairs, Regulatory Submissions, GMP, Regulatory Requirements, Dissolution and more. Demeitrius Sawickij has 2 emails and 2 mobile phone numbers on RocketReach.
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