Patel Pooja
Regulatory Scientist
Sydney, New South Wales, Australia
Summary
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Senior🎓
Top SchoolPooja Patel is a regulatory scientist with 10 years’ experience steering quality assurance and regulatory affairs across pharmaceuticals and medical devices for global markets including EMA, TGA, MHRA and WHO. She has a strong track record in dossier compilation (eCTD/CTD), device master files, QMS implementation and change-control investigations, helping products progress from pre-development to commercialization. Comfortable with both hands-on dossier submission and systems-level QMS design, she has led audits, SOP development, product quality reviews and regulatory responses under tight deadlines. Now based in Sydney and pursuing an M.Tech from University of Hyderabad, she blends technical regulatory expertise with recent exposure to Australian and international markets at companies from startups to multinational CSL. Notably, she pairs legal awareness of regulatory frameworks with practical software tools (Pharmareddy, Trackwise, SAP, eCTD platforms) to accelerate compliant product launches.
10 years of coding experience
2 years of employment as a software developer
Master of pharmacy, Quality assurance and regulatory affairs, Master of pharmacy, Quality assurance and regulatory affairs at GTUB.pharma, Pharmacy, B.pharma, Pharmacy at University Institute of Technology, RGPV
Github Skills (26)
java7
retail6
shopizer6
macos5
commerce5
linux5
windows5
ecommerce5
kubernetes4
desktop4
docker4
pastebin3
scrape2
rancher2
scraper2
Programming languages (4)
Github contributions (5)
Pooja269/CampusTalkAndroid
Mar 2016 - May 2016
Contributions:15 commits, 1 branch in 1 month
Pooja269/leetcode-problems
May 2020 - Jun 2020
Contributions:30 pushes, 1 branch in 1 month
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