Sr. Director, Regulatory Affairs @ CorePharma, LLC (acquired by Impax) (September 2012 - June 2017)
Director, Regulatory Affairs @ Dr. Reddy's Laboratories, Inc. (October 2010 - August 2012)
Director, Regulatory Affairs Pharmaceuticals @ B. Braun Medical Inc. (January 2005 - October 2010)
Kimberly Ernst Education
Cedar Crest College
Bachelor of Science - BS (Chemistry)
Lehigh University
Masters (Chemistry)
Kimberly Ernst Skills
Regulatory Submissions
Regulatory Affairs
21 CFR Part 11
Quality Auditing
R&D
CAPA
Clinical Development
eCTD
Cross-functional Team Leadership
GMP
Pharmaceutical Industry
Regulatory Requirements
GLP
Validation
Quality Assurance
Quality System
Program Management Skills
IND
Sop
FDA
ISO 13485
Biopharmaceuticals
Change Control
Design Control
GxP
Lifesciences
Technology Transfer
V
Cross Functional Team Leadership
Customer Service
Microsoft Office
Research
Pharmaceutical Sales
Marketing
Microsoft Excel
Sales
Business Development
Kimberly Ernst Summary
Kimberly Ernst, based in United States, is currently a VP, Quality and Product Developmemt at LTS Nasal and Sterile Drug Products. Kimberly Ernst brings experience from previous roles at LTS Nasal and Sterile Drug Products, Renaissance SSA, LLC, CorePharma, LLC (acquired by Impax) and Dr. Reddy's Laboratories, Inc.. Kimberly Ernst holds a Bachelor of Science - BS in Chemistry @ Cedar Crest College. With a robust skill set that includes Regulatory Submissions, Regulatory Affairs, 21 CFR Part 11, Quality Auditing, R&D and more. Kimberly Ernst has 3 emails on RocketReach.
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