Director, Regulatory Affairs @ Astellas Pharma US (January 2017 - January 2021)
Associate Director, Regulatory Affairs @ Astellas Pharma US (January 2014 - January 2017)
Member Board of Directors @ (January 2012 - June 2015)
Senior Manager Global Regulatory Affairs @ (January 2011 - January 2014)
Manager Global Regulatory Affairs @ (January 2006 - January 2011)
Project Manager Global Regulatory Affairs @ (January 2004 - January 2006)
Research Associate III - Sterility Assurance @ (January 2002 - January 2004)
Research Associate II - Sterility Assurance @ (January 2001 - January 2002)
Quality Assurance Scientist @ (January 2000 - January 2001)
Assistant Laboratory Manager - Animal Resources Center @ The University of Chicago (January 1999 - January 2000)
Senior Medical Technologist @ (January 1997 - January 1999)
Member Board of Directors @ (January 1997 - January 1999)
Research Technologist @ (January 1994 - January 1997)
Medical Technologist @ (January 1993 - January 1994)
Medical Technologist @ (January 1992 - January 1993)
Carol Soo Education
University of Cincinnati
Master of Science (MS) (Environmental Toxicology)
2002
Michigan State University
Bachelor of Science (BS) (Medical Technology)
1992
Carol Soo Skills
Immunology
Project Management
Regulatory Affairs
Customer Service
Microsoft Word
Regulatory
Process Improvement
Clinical Trials
Cardiovascular
eCTD
GMP
Process Parametric Release
Business Acumen
GxP
Steam Sterilization
Good Clinical Practice Gcp
ICH guidelines
Industrial Microbiology
Change Control
Team Leadership
Sterility Assurance
Trackwise
Quality Assurance
Fundraising
Grant Reviewing
Non Profit Program Development
Corrective And Preventive Action Capa
Compliance
Regulatory Requirements
NDA
Non Profit Board Development
U.S. Food And Drug Administration Fda
Regulatory Strategy Development
Regulatory Submissions
ANDA
Standard Operating Procedure Sop
Global Regulatory Compliance
Pharmaceutical Industry
Professional Mentoring
Therapeutic Areas
Grant Writing
CAPA
CMC Regulatory Affairs
FDA
Sop
21 CFR Part 11
IND
u.s. Food and Drug Administration
Corrective and Preventive Action
Standard Operating Procedure
Good Clinical Practice
Carol Soo Summary
Carol Soo, based in Hoffman Estates, IL, US, is currently a Senior Director, Regulatory Affairs at Astellas Pharma US. Carol Soo brings experience from previous roles at Astellas Pharma US, Synapse House and Baxter International Inc.. Carol Soo holds a Master of Science (MS) in Environmental Toxicology @ University of Cincinnati. With a robust skill set that includes Immunology, Project Management, Regulatory Affairs, Customer Service, Microsoft Word and more. Carol Soo has 1 emails and 1 mobile phone numbers on RocketReach.
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