Divnesh Kumar Singh
Professional Expert in Field of Regulatory Publishing | Regulatory Operations | Submission Managment | Regulatory Compliance
- Role
- Group Leader at MANKIND PHARMA LTD
- Location
- Ghaziabad, UP, IN
- LinkedIn followers
- 500 followers
General Business & ManagementView LinkedIn profile
About Divnesh Kumar Singh
OBJECTIVE To achieve a challenging & rewarding position in a growth-oriented…
Experience
Group Leader
Jul 2024 — Present · Gurugram, IN
Education
Sikkim Manipal University - Distance Education
Master of Computer Applications (MCA)
2011 — 2013
PharmaState Academy
Certification in Drug Regulatory Affairs
2023
Chaudhary Charan Singh University
Bachelor’s Degree
2007 — 2009
Skills
- Pharmaceutical Industry
- Abbreviated New Drug Application (Anda)
- Pharmaceutics
- Ema
- Regulatory Affairs
- Clinical Trials
- Regulatory Filings
- Pharmacovigilance
- Gmp
- Common Technical Document (Ctd)
- Good Laboratory Practice (Glp)
- Firstdoc
- Regulatory Requirements
- Electronic Common Technical Document (Ectd)
- Dcp
- Nees
- Validation
- Ectd Submission Specialist
- U.s. Food and Drug Administration (Fda)
- Nees and Ectd Publisher for Eu, Us and Em Market
- Formulation
- Regulatory Submissions
- Document Lifecycle Management
- Regulatory Documentation
- Standard Operating Procedure (Sop)
- Cp
- Global Submit
- Isi Toolbox
- New Drug Application (Nda)
- Sap Erp
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