Anupama GV
San Jose,USA
Overview
4
4
years of professional experience
1
1
Certification
Work History
Junior Regulatory Associate
Parexel International
06.2021 - 03.2022
- Used Insight Publisher (IP), Insight Validator (ISV) for publishing and submissions.
- Collect and coordinate information and prepare regulatory documentation for submissions.
- Preparations of Modules M1 to M5.
- Compilations of different types of submissions like Annual reports, Variations, and PSURs.
- Creating bookmarks, hyperlinking, TOC, Fast web view, and other activities in eCTD Submissions.
Apprenticeship
Mylan Laboratories
07.2018 - 05.2019
- Regulatory Affairs Dept (WHO Market).
- Working knowledge and experience with eCTD Modules.
- Prepare and submit regulatory documents for new marketing authorization applications and variations.
- Maintenance of data in relation status of ongoing regulatory activities for product.
Education
Master of Science - Regulatory Science
Arizona State University
Tempe, AZ12.2024
Master of Science - Pharmaceutical Analysis
JSS University
India05.2021
Bachelor of Science - Pharmacy
Osmania University
India04.2018
Skills
Publishing, Insight publisher, Insight Validator, eCTD, Word, Excel, Adobe Acrobat
Certification
- Regulatory Affairs Certification Course, Regulatory Affairs Professional Society (RAPS). June 2022 - Feb 2023.
- Certificate Program in Drug Registration, Dec 2019. Preparation and compilation of Dossier. Parts of Dossier, DMF and eCTD.
Publications
- Determination and quantification of Cypermethrin pesticide residue in cucumber using HPLC: This method is fast and economical. This can be used to find pesticides in vegetables like cucumber. The separation was performed on the Shimadzu UFLC instrument, which is supported by the C18 column.
- Bio-analytical method development and validation of Cypermethrin pesticide using GC-FID method: A very simple Gas chromatography technique was developed which helps in the estimation of Cypermethrin in human plasma. The drug was separated in the Zebron GC DB's drug column. The retention time was 18.2 mins.
- Quantification of Pyrimethamine using UFLC with Fluorescence detector: Pyrimethamine is an antiparasitic compound that is commonly used in the treatment of P. Falciparum malaria. The separation was performed on the Shimadzu UFLC instrument, which is supported by RP C18 column, empower software, and using a mobile phase of sodium phosphate pH 4.5.
Timeline
Junior Regulatory Associate
Parexel International
06.2021 - 03.2022
Apprenticeship
Mylan Laboratories
07.2018 - 05.2019
Master of Science - Regulatory Science
Arizona State University
Master of Science - Pharmaceutical Analysis
JSS University
Bachelor of Science - Pharmacy
Osmania University