pallavi choudhry
senior manager of regulatory affairs
About
I am a program manager in Regulatory Affairs with experience in both CMC and Clinical regulatory. I am currently the regulatory partner for a commercial product and maintain the license (IND and NDA annual report filings, PADER, Class Safety labeling update, PSUR ex-US) and a PM on a Phase II drug/device combination product going into Phase III. I have supported 4 sBLA filings for new indications on another commercial product (compiled Module 1, written 90/120 day safety update, OSI/BIMO guide), led USPI working groups for 2 indications and 2 device configurations, as well as all annual reporting for this product (PSUR, DSUR, IB update, Annual report, IND AR). I recently led an initial pediatric study plan submission and evaluated a pediatric study conducted by a partner company for filing in the US. I am looking to further expand my regulatory experience/leadership skills in other therapeutic areas and stages of development in a smaller environment.
united states
south san francisco
biotechnology
filing ind amendments, data verification, regulatory intelligence, post approval submissions, sds page, molecular biology, pcr, northern blotting, blast, western blotting, bacterial culture, clustalw, genscan, expasy, microsoft office suite, subcultures
Experience
senior manager of regulatory affairs
professional notetaker
asucd unitrans
Took notes and professor's comments, organized into narrative format with diagrams
student- biotechnology master's
san jose state university
As a student in the Mbt, I am taking many science based courses in biology including advanced molecular lab, bioinformatics, and seminars that teach about work in the industry, along with MBA level management courses.
medical science intern
abbott
* ● Condense off-label interactions and information from 3 different unlinked databases regarding products and/or vascular conditions * ● Extrapolate trends found in coronary, endovascular or structural heart disease queries from healthcare professionals * ● Create ideas on how to integrate databases and present all findings in a final presentation * ● Presented a commercialization/marketing strategy for nutritional products to be manufactured in Haiti at a conference hosted by senior executives in July 2012
research intern
uc davis
Worked on research project studying effect of calorie intake and diet types on longevity in mice Responsibilities include: weighing mice, collecting data, feeding, changing cages, preparing deceased mice for pathology
orthodontic assistant intern
dr nancy gum dds
* Made post- treatment plaster models * Cut wires, chains, restocked work stations * Filed, organized charts and post treatment models
regulatory program manager - ophthalmology and endocrinology
genentech
regulatory affairs project manager
genentech
Education
university of california, berkeley
physiology
university of california, davis
physiology
san jose state university
biotechnology
pallavi choudhry's Contact Information
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