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the treatment of serious diseases. Ardea is searching for a Director/Sr. Director, Regulatory & Scientific ... of INDs, BLAs, or NDAs in collaboration with Regulatory Affairs and other team members. Evaluate draft documents and...
production of INDs, BLAs, or NDAs in collaboration with Regulatory Affairs and other team members. *Evaluate draft ... E6 plus CFR 312 and 314. *Knowledge of Canadian and/or EU regulatory requirements is preferred. *General knowledge of...
and production facilities In collaboration with Director of Regulatory Affairs, interact with local and ... systems Direct experience of design and construction of larger scale facilities Experience managing personnel,...
the Director, Quality Assurance and will interact with IT, Regulatory Affairs, Drug Safety and Clinical Operations as ... Physical Demands/Work Environment: * Computer keyboarding 70% of time; * Handling of paper files and notebooks up to 20...