Amol Sonawane on Tal
Headline
Regulatory Affairs Executive | M.Pharm (Pharmaceutical Quality Assurance) | CTD, ACTD, Dossier Preparation | Aspiring Human Pharmaceutical Regulatory Affairs Professional
About
I am a Regulatory Affairs Executive with 1.6 years of experience in veterinary pharmaceutical regulatory affairs and hold an M. Pharm in Pharmaceutical Quality Assurance. My experience includes dossier preparation and compilation, regulatory documentation, product registration support, lifecycle management activities, and cross-functional coordination with R&D, QA, QC, Production, and Packaging teams. I have worked on regulatory submissions for ROW markets while ensuring compliance with applicable regulatory requirements and internal quality standards. I am now looking to transition into Human Pharmaceutical Regulatory Affairs, where I can apply my regulatory knowledge while expanding my expertise in global markets, including the US FDA, EMA, MHRA, and other international regulatory agencies. I am actively strengthening my knowledge of CTD/eCTD submissions, EU procedures, lifecycle management, variations, renewals, and global regulatory guidelines. I am passionate about continuous learning, regulatory compliance, and contributing to the successful development and registration of high-quality pharmaceutical products. Core Skills: • Regulatory Affairs • CTD & ACTD Dossier Preparation • Regulatory Documentation • Product Registration • Lifecycle Management • Variations & Renewals • Change Control • GMP Documentation • Coordination with R&D, QA, QC & Production • Microsoft Office (Word, Excel, PowerPoint) I am open to opportunities in Human Pharmaceutical Regulatory Affairs, particularly in Pune, PCMC, and other major pharmaceutical hubs.
Work experience
Regulatory Affairs Executive at Vetox Healthcare Pvt Ltd, Nov 2024 - Present · 1 yr 9 mos, Pune District, Preparation and submission of dossier, COA, CMC, handling market complaints | ROW Market
IPQA Executive at Blue Cross Laboratories Ltd., Nov 2023 - Oct 2024 · 1 yr, Goa, India, Performing Inprocess Quality Assurance, Line clearance, Product dispatch, Sample collection, Maintaining quality documents.
Apprentice at Blue Cross Laboratories Ltd., Nov 2023 - Oct 2024 · 1 yr, Goa, India, 8 months of experience in the department of IPQA.
Education
Master's degree, Pharmaceutical Quality Assurance, AISSMS College of Pharmacy - India
Bachelor of Pharmacy - BPharm, Pravara Rural Education Societys Pravara Rural College of Pharmacy, Pravaranagar, Dist.Ahmednagar 413736
