Shivam Singh
Regulatory affairs Professional
- Role
- Officer at Rusan Pharma Ltd
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Shivam Singh
Postgraduate in chemistry and experienced in Quality control as an executive.
Experience
Officer
Nov 2025 — Present
RA API, knowledge of ICH guidelines (Q1-Q14).• Review of specification for Raw materials, in-process and finished products, review of Method of analysis, to report any change control and table of changes. And documents for DMF compilation.• Assistant for DMF preparation and Documentation.• Knowledge of ECTD format and review of DMF as per ECTD and compilation of DMF.• Knowledge of Module 1-5 for Active pharmaceutical ingredients registration.• Review of Method development report, Analytical Method Validation/verification protocol and report.• Working cross functionally with R&D, QC and QA for collection of documents for API registration in US, EU and other market.• To report any update in ICH, and country specific guidelines and looking after lifecycle management of API and CEP received.• Maintaining database to track API, projects initiation to DMF filing using Excel sheet and MS-word.
Education
University of Mumbai
Msc, Msc chemistry
Institute of Pharmaceutical Management
Associate's Degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
Institute of Science
Master of Science, Physical Chemistry
University of Mumbai
Bsc chemistry, Chemistry
Institute of pharmaceutical management
Advance Diploma in formulation and API, Regulatory affairs
Patkar Varde College
Bachelor of Science, Chemistry
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