Prachi Ojha
Regulatory Specialist
- Role
- Regulatory Specialist at Tag
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Prachi Ojha
Reliable and focused Regulatory Affairs Specialist with Master’s in Pharmacology and hands on business experience in dossier review and evaluation. Well versed with USFDA regulatory guidelines for generic drug development as well as ICH guidelines. Hands on experience with Veeva Vault ( quality docs as well as RIMS) Superb multitasker able to handle multiple projects efficiently and accurately.Skills: Dossier Review and Compilation~ CMC Regulatory Affairs ~ Injectables ~OSD~Abbreviated New Drug Application (ANDA)~ Veeva vault~ Annual Reports ~ DMF Review ~ ICH Guidelines~ USFDA Guidelines ~ Project Management ~ Regulatory Strategy ~ Post Approval Applications ~ Cross Functional Coordination CONTACT INFORMATION: p•••••••@gmail.com
Experience
Regulatory Specialist
Jan 2024 — Present
Education
Kle College of Pharmacy Belgaum
Bachelor of Pharmacy, Pharmacy
2015 — 2019
Kle College of Pharmacy Belgaum
Master of Pharmacy, Pharmacology and Toxicology
2019 — 2021
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