Jinhe Zhao
Manager Regulatory CMC Strategy
Malden, Massachusetts, United States
Summary
👤
Senior🎓
Top SchoolJinhe Zhao is a seasoned CMC regulatory strategist with 11 years’ experience leading IND/NDA/ANDA submissions, GMP compliance, and global dossier authoring across ICH regions. Currently Manager of Regulatory CMC Strategy at Viatris, he designs submission strategies, risk assessments, and technology-transfer plans for complex post-market and new-launch programs. He has hands-on experience with EU and US GMP inspections for sterile oncology parenterals and has served as an interpreter during multiple FDA inspections, giving him rare insight into regulator-sponsor communications. Jinhe has led IND CMC packages and breakthrough therapy interactions, managed CEP and API registrations, and successfully navigated cross-border regulatory requirements from China to Europe and the US. Trained with a Master of Regulatory Affairs from Northeastern and a pharmacy degree in English, he combines technical lab-facing knowledge with strategic regulatory planning. Colleagues describe him as self-motivated and pragmatic, able to translate detailed CMC complexities into clear, auditable regulatory outcomes.
11 years of coding experience
4 years of employment as a software developer
Bachlor, Pharmacy (English), Bachlor, Pharmacy (English) at Shenyang Pharmaceutical UniversityMaster of Regulatory Affairs, Master of Regulatory Affairs at Northeastern University
Github Skills (20)
react6
messaging6
p2p4
encryption3
javascript3
typescript2
decentralization2
infrastructure2
vue2
sfu1
end-to-end-encryption1
cross-platform1
screensharing1
sctp1
ice1
Programming languages (2)
Github contributions (5)
curltech/CollaChat
Mar 2021 - May 2022
A private and decentralized messaging app owned by no one and everyone.
Contributions:136 commits, 2 PRs, 126 pushes in 1 year 2 months
reactp2pdecentralizedmessaging-appmessaging
goldjinhe/homerepair
Oct 2015 - Jul 2016
Contributions:686 pushes, 3 branches in 8 months
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