* Build and maintain a collaborative relationship with FDA by interfacing with reviewers, division heads, etc. (as appropriate) and negotiating resolution of regulatory issues affecting product development
* Develop effective proactive regulatory strategies/Negotiate complex regulatory issues for product development and earliest market approval, and recommend such strategies to team members and management
* Provide strategic RA guidance to APP business disciplines regarding desired revisions to products as well as the rectification of product issues that may arise
* Provides guidance to team for the preparation and filing of high quality submissions to regulatory authorities, such that all applications are filed in accordance with predetermined timelines and only minor FDA deficiencies are received
* Manage and prioritize the team's workload in accordance with the goals established by senior management
* Participate in the hiring, training, and management of direct reports to ensure successful performance and career growth
Posted @ 10:08AM, July 04, 2007
by Toni Glinsey | Permalink
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