FDA- Generic Drug Policy Regulatory Counsel- FDA/CDER/OGDP/DLRS
Duties/Responsibilities Develops policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products. Drafts or critically reviews documents embodying policy and program proposals and decisions on these products. These documents state or interpret Center or FDA policy for the regulated industry and other affected groups and receive minimal review before transmittal to management or other stakeholders. Reviews policy and other regulatory documents drafted by other offices that impact generic drug regulation. Drafts revisions and technical corrections to new and existing regulatory documents. Serves as an expert consultant on the generic drug regulatory review process within FDA and to other inter
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