Panpan Gu
China Asset Strategy Lead - Oncology @ AbbVie
About
More than 13 years working experiences in project/portfolio management across different functional teams like clinical development, regulatory affairs, and regulatory operation. PMP certified project manager with solid project management knowledge and skills.
China
Yangpu District
Pharmaceuticals
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, English, Outlook, Public Speaking, Budgets, Editing, Strategic Planning, Negotiation, PMP certification, 制药业, 肿瘤学, 生命科学, 临床研究, 项目管理, 临床开发, 法规事务
Experience

Regulatory affairs and project management
中国 上海市 浦东新区
Define filing strategy for new biologic assets in pipeline to mainstream countries like US and EU with the collaborations with external consultants (FDA former reviewers) and internal cross functional teams to . Lead/Coordinate entire IND/NDA processes. Hold regional strategic meeting for new drug application, Solve problems during the application within company to ensure smoothly approval; Track and analyze latest policies and regulatory development from worldwide agency site, establish and update internal regulatory database for a timely basis.

Hub Submission Manager (Asia Hub)
Shangahi
Responsible for Asia regional and national regulatory submission dossier build and delivery. Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate. Partnering with product teams.
Education

Drug Development and Regulatory Sciences
The "Chinese Course on International Innovative Drug Development and Regulatory Science (CCDRS)" was jointly established in 2009 by the Peking University Clinical Research Institute, the University of California, San Francisco (UCSF), and the University of Basel, Switzerland. The course offers comprehensive, systematic, and complete insights into the entire process of innovative drug development and regulatory management, presenting the most advanced concepts and successful practices. It provides opportunities for case-based learning and face-to-face discussions with experts, helping participants master scientific, effective, economical, and forward-looking methods for drug development and regulation. The goal is to cultivate professionals in China with a thorough and systematic understanding of modern drug development and management, thereby contributing to China’s development of a competitive pharmaceutical industry.
Panpan Gu's Contact Information
Phone
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