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Director of Licensing

Responsible for new product licensing and modifications
and maintenance of existing product licenses in
North America. Regulatory oversight of a diverse
array on biotechnology products and manufacturing
facilities. Extensive interaction with the U.S. FDA
and with Canadian HPB. Will direct and execute the
strategic plan of the Regulatory Affairs product and
licensing function. Direct a staff of 3 Regulatory Affairs
Managers across multiple facilities with specialists
reporting to them (total 12). Interface internally and
externally with colleagues and regulators to ensure
realization of business goals and coordination of regulatory activities on a global level. Oversight of budget for
licensing function and ensures appropriate
resources are available.

Requirements: Degree in Biological Sciences.
Advanced Degree in life sciences (preferably PhD).
7-10 years regulatory experience with at least
5 years in pharmaceutical or biotechnology. Extensive
knowledge of US biologics regulation. Must have
excellent negotiation skills, broad business focus,
verbal and written communication skills.