Saurabh Kumar Singh
Global Regulatory Affairs || Regulatory Information Management System (RIMS) || WIZARD || CMC Regulatory || M. Pharm
- Role
- Regulatory Intelligence Associate at RegDesk
- Location
- New Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Saurabh Kumar Singh
As a Drug Regulatory Affairs Executive with extensive experience in the Rest of the World…
Experience
Regulatory Intelligence Associate
Dec 2024 — Present · Mohali, IN
Collect, Interpret, and Compile the scientific data from the various regulatory sources ( viz. EU, UK, ASEAN,AFRICAN )in the Regulatory Information Management System (RIMS) software and Maintain the database on real-time basis.• Regulatory review and compilation of Dossiers on CTD/ACTD format in compliance to regulations andICH guidelines.• Review Dossier and Technical Documents such as PDR, MFR, BMR, BPR, COAs, Labelling material,Specifications, Process validation protocol, and Stability reports for assigned projects.•Communicate with Regulatory agencies regarding required information in a timely manner, and maintainthe records.•Responsible for keeping a track of current changes in regulatory legislation and guidelines and providingupdated information to the various client servers on a daily basis.• Maintain knowledge of and understand worldwide regulatory guidelines like ICH, WHO,etc
Education
Bundelkhand University
Bachelor of Pharmacy
Dr. A.P.J. Abdul Kalam Technical University (AKTU), Lucknow
Master Of Pharmacy
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