Tony Dongye Zhang
Senior Manager, Global Regulatory Strategy Us & Canada @AbbVie
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WORK HISTORY
Senior Manager, Global Regulatory Strategy Us & Canada @AbbVie
Supported the QULIPTA sNDA approval for preventive treatment of migraine in adults • Responsible for ensuring planned drug development activities comply with health authority guidelines and in cases where they do not, provides a critical analysis of associated risks and issues • Make recommendations to Regulatory Management and drug development teams in order to shape the global strategy in line with commercial objectives. • Support the drug development strategy; defining options for Scientific Advice, creating briefing packages, and coordinating and leading US health authority meetings. • Define global submission strategies, identifying risks and issues. • Ensure that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during development, lifecycle management. • Develop an awareness of key individuals within the Regulatory Agencies, to ensure a clear understanding of requirements and effective representation of AbbVie. • Submit product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes to relevant functions. • Provide project teams with clear constructive regulatory advice and intelligence to maximize business opportunities. • Define regulatory requirements, develops and subsequently implements, plans in support of global/regional/country business initiatives. • Provide input into development of processes to leverage global processes and infrastructure and maximize efficiency and effectiveness.
EDUCATION
Cornell University
Master of Biomedical Engineering, Bio-instrumentation and Therapeutic Devices
Stony Brook University
Doctor of Philosophy (Ph.D.), Biomedical Engineering, School of Engineering and Applied Science
ABOUT TONY DONGYE ZHANG
Over 6 years of consulting and financial advisory training in biotechnology…
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