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John Andre Location
Florida, United States
John Andre Work
Senior Director of Regulatory Affairs @ (September 2016 - Present)
Senior Director, Regulatory Affairs @ (August 2014 - January 2016)
Director, Regulatory Affairs @ (February 2010 - August 2014)
Manager Regulatory Affairs @ (May 2004 - February 2010)
Senior Regulatory Affairs Associate @ (February 1995 - May 2004)
John Andre Education
PU
Bachelor Of Science (Microbiology)
1989-1993
John Andre Skills
21 CFR Part 11
ANDA
Aseptic Processing
Auditing
Biopharmaceuticals
Biotechnology
CAPA
Change Control
Cleaning Validation
Clinical Development
Clinical Trials
Computer System Validation
Cross-functional Team Leadership
Design Control
Document Management
Drug Development
FDA
FDA GMP
GLP
GMP
GxP
HPLC
IND
ISO 13485
ISO 14971
LIMS
Laboratory
Lifesciences
Manufacturing
Medical Devices
Microbiology
Pharmaceutical Industry
Pharmaceutics
Product Development
Quality Assurance
Quality Auditing
Quality Control
Quality Management
Quality System
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Software Documentation
Sop
Technology Transfer
Trackwise
V&V
Validation
eCTD
John Andre Summary
John Andre, based in Florida, United States, is currently a Senior Director of Regulatory Affairs at Athenex. John Andre brings experience from previous roles at Crealta Pharmaceuticals, LLC, Regulatory Compliance Associates, Inc., Hospira, Inc. and Abbott Laboratories. John Andre holds a 1989 - 1993 Bachelor Of Science in Microbiology @ PU. With a robust skill set that includes 21 CFR Part 11, ANDA, Aseptic Processing, Auditing, Biopharmaceuticals and more. John Andre has 1 emails and 5 mobile phone numbers on RocketReach.
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