Jessie Kim
Senior Manager, Global Regulatory Affairs CMC | UCB | Neurology (Epilepsy)
- Role
- Senior Manager, Global Regulatory Affairs Cmc at UCB
- Location
- Atlanta, GA, US
- LinkedIn followers
- 500 followers
About Jessie Kim
Regulatory Affairs CMC professional with experience supporting CNS programs, including epilepsy indications, across small-molecule and drug-device combination products. Background includes oral solutions, actuator-based systems, and breath-actuated inhalation delivery platforms. Skilled in Module 3 development, regulatory impact assessment, and aligning cross-functional and external contributions into structured, submission-ready dossiers.
Experience
Senior Manager, Global Regulatory Affairs Cmc
May 2023 — Present · Atlanta, GA, US
Drive CMC regulatory strategy for clinical development and post-approval changes across US, EU, JP, and CN.• Own development and critical review of key Module 3 sections for IND/IMPD amendments, NDA updates, annual reports, and agency responses.• Lead regulatory impact assessment for manufacturing, analytical, packaging, and device change.• Direct NDA readiness planning for assigned assets, including dossier structure, data expectations, and risk identification.• Serve as primary CMC regulatory partner to Device, Quality, Technical, and Supply Chain functions.• Oversee integration of internal and external technical inputs into structured, submission-ready eCTD dossiers.
Education
The University of North Carolina at Chapel Hill
Doctor of Pharmacy - PharmD, Pharmacy
2017 — 2021
NC State University Graduate School
Master's degree, Physiology, General
2014 — 2016
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