Dalyn Valentin-Shawver
Global Regulatory Affairs Fellow at GSK
- Role
- Post-doctoral Global Regulatory Affairs Fellow at GSK
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Dalyn Valentin-Shawver
As a Global Regulatory Affairs Fellow, I’ve had the opportunity to contribute…
Experience
Post-doctoral Global Regulatory Affairs Fellow
Jul 2024 — Present
Prepared and reviewed IND submissions, including first time in human initial INDs, amendments, and annual reports in compliance with FDA regulationsContributed to EU CTR submissions via CTIS, including document upload, interim access setup, and RFIsDeveloped a dynamic spreadsheet to streamline FDA Type C/D meeting planning, enabling real-time discussion of timelines and key datesServed as the regulatory representative on cross-functional teams to support early- and late-stage clinical trial documentation and strategyCoordinated briefing documents and background materials for FDA Type C and D meetingsAdvised project teams on submission strategies, document requirements, and regulatory risks
Education
University of Central Florida
Bachelor of Science - BS, Chemistry
2017 — 2020
The University of North Carolina at Chapel Hill
Postdoctoral Fellowship
University of Florida
Doctor of Pharmacy - PharmD
2020
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