* Interact with R&D and business units to provide regulatory strategy and support for drug development projects to insure the timely submission, approval, and registration of new products/indications and maintain approval for marketed products
* Prepare and file IND/NDA/eNDA submissions and other regulatory documents with the FDA while simultaneously training more junior colleagues
* Insure product quality, manufacturing efficiency, and provide regulatory strategy/support for drug development
* Define regulatory requirements and review the completeness and accuracy of data submitted by project team members for inclusion in regulatory submissions to the Agency
Posted @ 10:13AM, July 04, 2007
by Toni Glinsey | Permalink
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