PRIYA PANDYA
REGULATORY AFFAIRS EXECUTIVE
AHMEDABAD
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. I excel in resolving client queries and fostering collaboration. Strong analytical skills complemented by effective communication drive successful project outcomes. Committed to delivering impactful results and enhancing company performance.
Overview
2
2
years of professional experience
Work History
Regulatory Affairs Executive
Swiss Parenterals LTD
10.2022 - 09.2024
- Working as Executive in Regulatory Affairs in Swiss Parenterals LTD.
- Preparing dossier for registration and re-registration for Different countries.
- Resolving and response to Queries rising from clients with in given timelines.
- Resolving and response to Ministry queries rising from Clients with in given timelines.
- Working on Purchase order from different countries.
- Sending Documents and samples to different countries for registration and re-registration.
- Reviewing artworks for registration of dossier.
- Other work as assigned based on the project and company needs.
Education
High School Diploma -
M.K. Patel High School
04.2001 -
B.Pharm
Institute of Pharmacy Nirma University
Ahmedabad, India06-2020
M.pharm
National Forensic Sciences University
Gandhinagar, India06-2022
Skills
TECHNICAL SKILLS:
UV-Vis,FT-IR,DSC,Dissolution apparatus,High speed & High pressure homogenizer, Rotary Evaporator, Centrifuge, Zeta analyzer(Malvern), Zeta analyzer(Horiba)
REGULATORY AFFAIRS:
Have sound knowledge of ICH Guideline, ANDA, NDA Approvals and BA/BE Studies, CTD Triangle, ACTD Triangle, 505(b), Drug Registration in EU, Mexico, Kosovo and in ASEAN market
ORGANIZATIONAL SKILLS:
Group Discussion, Oral Presentation, Leadership, Team work, Communication
COMPUTATIONAL SKILLS:
MS Word, Excel, Power point,Pharma cloud software
LANGUAGE KNOWN:
Hindi,English,Gujarati
Additional Information
Mr.Nisarg Patel
(Deputy General Manager, Swiss Parenterals LTD)
8690366842
Mr.Girish Dudhat
(Manager, Swiss Parenterals LTD)
9601460243
Timeline
Regulatory Affairs Executive
Swiss Parenterals LTD
10.2022 - 09.2024
High School Diploma -
M.K. Patel High School
04.2001 -
B.Pharm
Institute of Pharmacy Nirma University
M.pharm
National Forensic Sciences University