Ja-Young Lee Email
Global Regulatory Affairs RA Manager in Global Business Development and License at Sandoz @ Sandoz
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Ja-Young Lee Location
- Leipzig, SN, DE
Ja-Young Lee Work
- Global Regulatory Affairs RA Manager in Global Business Development and License at Sandoz @ (July 2018 - Present)
- Manager Regulatory Affairs at Cinfa (current Mundipharma) @ Cinfa Biotech (November 2015 - June 2018)
- Manager Regulatory Affairs APAC @ (July 2011 - October 2015)
- Manager CMC Documentation at Micromet (current Amgen) @ (December 2010 - June 2011)
- Regulatory QA Documentation EMP project @ (October 2008 - November 2010)
- Project Manager @ Weylchem GmbH in Mannheim (September 2007 - August 2008)
Ja-Young Lee Education
- TU Dortmund University
Postdoc
2005-2007 - University of Stuttgart
Promotion (Organic and Analytical Chemistry)
2001-2004 - Seoul National University
Bachelor's degree (Pharmacy)
Ja-Young Lee Skills
- Artificial Intelligence (AI) in Regulatory Affairs
- CTD / eCTD (Modules 1 & 3)
- Cross-Cultural Support for Regulatory Due Diligence (EU – Asia)
- Cross-Cultural Training & Workshops
- EMA Procedures (DCP / MRP / CP) and UK/Switzerland Procedures
- Global Regulatory Strategy (EU and International)
- Health Authority Interactions (EMA / RMS / CMS/MFDS/ANVISA/TGA)
- ICH Guidelines (Q1–Q12)
- Post-Approval Lifecycle Management
- RegCMC
- Regulatory Affairs (EU and International)
- Regulatory Due Diligence & CMC Risk Assessment
- Regulatory Intelligence (CMC)
Ja-Young Lee Summary
- Ja-Young Lee, based in Leipzig, SN, DE, is currently a Global Regulatory Affairs RA Manager in Global Business Development and License at Sandoz at Sandoz. Ja-Young Lee brings experience from previous roles at Cinfa Biotech, Sandoz, Micromet AG and Abbott Laboratories. Ja-Young Lee holds a 2005 - 2007 Postdoc @ TU Dortmund University. With a robust skill set that includes Artificial Intelligence (AI) in Regulatory Affairs, CTD / eCTD (Modules 1 & 3), Cross-Cultural Support for Regulatory Due Diligence (EU – Asia), Cross-Cultural Training & Workshops, EMA Procedures (DCP / MRP / CP) and UK/Switzerland Procedures and more. Ja-Young Lee has 1 emails on RocketReach.
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