Yameng (Melly) Lin

Melly Lin has more than sixteen years of experience in regulatory affairs. In her current postition of Senior China Regulatory Advisor, Roche, she is responsible for liaising with development and marketed product teams to ensure that China requirements are incorporated in products planning strategies, to drive acceleration in filing and approval timelines, and maximize early access of Roche medicines in China using innovative regulatory approaches. Before joining Roche Basel, she was Head of China Technical Regulatory Policy in Roche China. She was responsible for leading a cross-functional team to develop all technical regulatory policy and influencing efforts in China, including the establishment of strong and effective relationships with the Chinese regulatory agencies, as well the local pharmaceutical industry associations. In addition, she provides strategic advice and solutions to Technical Regulatory Leads for CMC related issues of development and marketed products in China. In 2009 and 2010, Melly had a rotational position in Roche headquarter in Basel as Regional Manager for 1.5 years, where in addition to providing support for registration activities in China and Hongkong, she joined several project teams to gain experience in global product development as well as regulatory submission requirements in the EU and developing countries. Prior to that, Melly worked as regulatory manager in Roche China and had responsibilities for clinical trial applications as well as NDA and commercial support for a variety of projects. Since 2011, Melly has represented Roche at CMC and Biological Focus Groups of R&D-based Pharmaceutical Association Committee (RDPAC) to advocate industry’s interests by developing position papers and organizing meetings and workshop with CFDA. As an individual member, she is also very active at DIA and was selected as member of DIA China Advisory Committee since 2015. She organized many sessions on hot topics in biological and CMC areas at China DIA to promote the scientific dialogue among industry, regulatory agency and academia. Melly got her Bachelor Degree from Shenyang Pharmaceutical University in 2001 and Master Degree in International Pharmaceutical Engineering Management from Peking University in 2016.