Manager, Regulatory Licensing @ (August 2013 - March 2015)
Sr Regulatory Affairs Specialist @ Talecris Biotherapeutics, Inc. (January 2009 - January 2013)
Amy Johnson Education
University of Mount Olive
Bachelor's degree (Business Administration and Management, General)
1997-2000
Amy Johnson Skills
21 CFR Part 11
Biopharmaceuticals
CAPA
Change Control
Computer System Validation
Electronic Common Technical Document (eCTD)
FDA
GMP
GxP
IND
Pharmaceutical Industry
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
SOP
Validation
eCTD
Amy Johnson Summary
Amy Johnson, based in Emerald Isle, NC, US, is currently a Director Product Regulatory Affairs at Aimmune Therapeutics. Amy Johnson brings experience from previous roles at ICON plc, Grifols, Grifols Inc. and Talecris Biotherapeutics, Inc.. Amy Johnson holds a 1997 - 2000 Bachelor's degree in Business Administration and Management, General @ University of Mount Olive. With a robust skill set that includes 21 CFR Part 11, Biopharmaceuticals, CAPA, Change Control, Computer System Validation and more. Amy Johnson has 1 mobile phone numbers on RocketReach.
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