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Shefalee Kapadia

Regulatory Affairs Manager at Monsanto


Summary
Develop expertise in seeking approvals of biotechnology derived plant products using scientific knowledge,
understanding of US and global regulations that govern biotechnological advancements, and expanding my
experience by working on diverse products in Monsanto's pipeline.
Experience
Regulatory Affairs Manager at Monsanto
October 2010 - Present (3 years 9 months)
Develop Regulatory approval strategies, execute project plans for data generation, prepare submission
documents for US and global agencies, and seek approvals for plant Biotech products as they advance in the
Monsanto pipeline.
Protein Biochemist at Monsanto
May 2005 - September 2010 (5 years 5 months)
Protein Analyst at Pfizer
March 2004 - May 2005 (1 year 3 months)
Languages
Hindi
(Limited working proficiency)
Marathi
(Native or bilingual proficiency)
Skills & Expertise
Regulatory Affairs
Regulatory Submissions
Regulatory Requirements
Regulatory Documentation
Regulatory Agencies
Regulatory Guidelines
Project Management
Project Coordination
Cross-functional Coordination
License Management
International Relations
Product Safety
Biotechnology
Environmental Biotechnology
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RNAi
Protein Purification
Protein Expression
Protein Chromatography
Protein Chemistry
Molecular Biology
Technology Transfer
Environmental risk assessment
Data Transport
Corn
Soybean
Agronomy
Education
University of Missouri-Saint Louis
Master of Science (M.S.), Biology/Biotechnology, 2004 - 2006
University of Missouri-Saint Louis
Bachelor's of Science, General Studies, 1998 - 2000
University of Mumbai
Bachelor of Science (BS), Microbiology, General, 1991 - 1994
Interests
Science, travel, music, food
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Shefalee Kapadia
Regulatory Affairs Manager at Monsanto
Contact Shefalee on LinkedIn
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