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Thursday, July 15, 2010

Regulatory CMC Project Leader BIosimilars

Our client is looking for Regulatory CMC Project Leader BIosimilars for their operations in Israel.

Description:

Regulatory input on, management and coordination of CMC issues/activities for biosimilar projects and preparation of the CMC parts of regulatory submissions

Requirements:

M.Sc in Pharmaceutical Sciences/Pharmacy/Biology/Biotechnology/Biochemistry
3-5 years' experience with biotech submissions ideally both US and EU
Up to date with CMC regulatory requirements, guidelines, etc
Understanding of the regulatory process in new drug development
Ability to analyze and evaluate biotech processes
Leadership abilities, open minded, flexibility but still assertiveness
Good writing skills, organization, communication and team work skills
Fluent spoken and written English

for immediate consideration please email your resume as well as
your Israeli ID # to: resume@hrglobalservice.com

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