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14th Annual Pharma Regulatory Affairs
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Sophia Huang
Senior Director/Regional Group Head, Regulatory Submission Management Beijing at Bayer Healthcare Company Limited

Profile

Sophia Huang currently works in Bayer Development Beijing, and has been the site head of Regulatory Submission Management 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 EU (NP & MRP/DCP) and emerging eCTD countries (i.e. Gulf countries, South Africa etc.) including internal process establishment support, promotion of eCTD knowledge, compilation and submission work within the whole eCTD lifecycle for Bayer’s Pharma portfolios. In addition, since 2016, Sophia’s team took over the electronic submission support for OTC portfolios globally except the United States. NMPA/CDE showed interest on eCTD implementation in China since 2015. 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.

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.

Agenda Sessions

  • Presentation: Regulatory Submissions & Approvals

    14:20