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Pradnya V. - 15340
Toronto, Canada
6:59 PM, GMT -04:00
Pradnya V. - 15340 Regulatory Affairs Associate from Toronto
About
1. Experienced in assembling components of Chemistry, Manufacturing, Control (CMC), and Quality Overall Summary (QOS) for eCTD submissions of pharmaceutical products as per FDA and ICH guidelines
2. 5+ years of research experience in pharmaceutical science by managing scientific research, conducting data analysis, and effectively communicating scientific findings through peer-reviewed publication
3. Technical expertise in the development of oral solid dosage form using various pharmaceutical technology
Occupation
Regulatory Affairs Associate
Work experience
2020 - 2021
Regulatory Affairs Executive
Encube Ethicals Pvt. Ltd., Mumbai
2020 - 2020
Ferring Pharmaceuticals Pvt. Ltd., Mumbai
Senior Research Fellow
Education
2012 - 2019
Institute of Chemical Technology, Mumbai, India
Doctorate in Pharmaceutical Sciences & Technology
2009 - 2011
Institute of Chemical Technology, Mumbai, India
Masters in Bioprocess Technology
2005 - 2009
Institute of Chemical Technology, Mumbai, India
Bachelors of Pharmacy
Skills
Adobe Acrobat
8 Y
Word
8 Y
Other skills
critical analysis and interpretation
Design-Expert® software
Microsoft Office-Excel
Patent and non-patent Literature search
Power point
Working knowledge of ICH and FDA guidelines
About
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