As a Drug Regulatory Affairs professional, my expertise lies in ensuring the safety, efficacy, and compliance of pharmaceutical products in the market. I am skilled in managing the process of drug registration and re-registration, and have experience in auditing and quality control. I have also been responsible for pre-shipment work and artwork and layout approval, ensuring that all packaging and labeling are in compliance with local and international requirements.
Hi, I’m
Versha Panwar
Drugs Regulatory Affairs Specialist
Malviya Nagar, Delhi
Summary
Overview
2
years of professional experience
5
years of post-secondary education
3
Certifications
Work History
Troge Medical GMBHNew Delhi
Junior Research Scientist
08.2021 - Current
Job overview
- Prepared and submitted regulatory file applications and supporting documentation
- Artwork and layouts approval for Pharmaceutical products and Medical Devices
- Conducted Audit of Pharmaceutical plant for sterile manufacturing
- Comparison of BP monograph and USP monograph
- Consolidated global information relevant to Armenia, Ghana, Mauritania, Cameroon and monitored global submissions and approvals status of registration and re-registration of dossiers
- Pre-shipment work including testing, making inspection reports
National Center for Disease Control (NCDC)New Delhi
Intern
06.2020 - 07.2020
Job overview
- Completed research, compiled data, updated spreadsheets, and produced timely reports on Covid-19 national data
- Identified bugs in data collection or reporting and investigated root causes.
Education
Indian Institute of Public HealthNew Delhi
Master of Science from Clinical Research
07.2019 - 07.2021
University Overview
Indira Gandhi National Open UniversityNew Delhi
Bachelor of Science from Zoology
07.2015 - 07.2018
University Overview
Skills
Britich/European Pharmacopoeia
CE Marking
Regulatory Documentation
Regulatory Affairs
Corrective And Preventive Actions (CAPA)
Good Manufacturing Practices (GMP)
Common Technical Document (CTD)
Quality assurance controls
Certification
Good Clinical Practice Certificate from NIDA Clinical Coordinating Centre
Timeline
Junior Research Scientist
Troge Medical GMBH
08.2021 - Current
Intern
National Center for Disease Control (NCDC)
06.2020 - 07.2020
Indian Institute of Public Health
Master of Science from Clinical Research
07.2019 - 07.2021
Indira Gandhi National Open University
Bachelor of Science from Zoology
07.2015 - 07.2018