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Sophia Huang Head of Regulatory Submission Management & Planning Beijing at Bayer Healthcare Company Limited

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Sophia Huang currently works in Bayer Development Beijing, and has been the site head of Regulatory Submission Management & Planning Beijing since 2015. Her team contributes in Global Dossier Publishing for new drug application in EU and US; and is also responsible for eCTD publishing in emerging eCTD countries (i.e. Gulf countries, South Africa etc.) for Bayer’s Pharma portfolios. Since 2015, CFDA/CDE showed interest on eCTD implementation. Sophia, as representative of Bayer in both CDE and RDPAC eCTD core working groups, contributes to promote eCTD knowledge to Chinese Pharmaceutical industry; share global experience with HA. In addition, since 2016, Sophia’s team took over the electronic submission support for OTC portfolios globally except the United States.

Sophia joined Bayer in 2009, and has been in different positions:  site head of Regulatory Compliance Management Beijing, and then Senior GRA Manager (worked in Bayer’s headquarter in Germany). She graduated from Edinburgh Napier University in UK in 2007 with a master’s degree in biomedical sciences.

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