2011 -2014 Senior Manager Global Regulatory Affairs @
2006 -2011 Manager Global Regulatory Affairs @
2004 -2006 Project Manager Global Regulatory Affairs @
2002 -2004 Research Associate III - Sterility Assurance @
2001 -2002 Research Associate II - Sterility Assurance @
2000 -2001 Quality Assurance Scientist @
1999 -2000 Assistant Laboratory Manager - Animal Resources Center @
1997 -1999 Senior Medical Technologist @
1997 -1999 Member Board of Directors @
1994 -1997 Research Technologist @
1993 -1994 Medical Technologist @
1992 -1993 Medical Technologist @
Carol Soo Education
University of Cincinnati
Master of Science (MS) (Environmental Toxicology)
Michigan State University
Bachelor of Science (BS) (Medical Technology)
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 2 emails and 1 mobile phone numbers on RocketReach.
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