Director, Regulatory Operations
We focus on in-licensing innovative drug candidates that are undergoing or have already completed initial clinical testing for the treatment of various forms of cancer and then seek to further develop these drug candidates for commercial use.
Regulatory professional with over 10 years of regulatory information management experience. Responsible for leading regulatory submission and document management process, including document publishing for the United States, European Union, Canada, and other regions. Support the development of processes and systems for Global Regulatory Affairs and Regulatory Operations. Specialties: Strong leadership and motivational skills. Proven ability to build rapport quickly, train and motivate people of all levels to achieve their maximum potential while attaining corporate objectives. Quickly assess problems and execute viable solutions to benefit all involved parties Experienced leading both technical and non-technical teams on a national and global scale Experienced working with regualtory agencies
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