As Regulatory Counsel, the incumbent assumes primary responsibility for ensuring that regulations and policies developed in the assigned area are consistent with statutory requirements and existing policy; that their need is justified, and that scientific and regulatory decisions have been appropriately documented. The Regulatory Counsel handles highly complex and difficult assignments of national scope and significance. Reviews petitions raising issues that have an effect on the generic industry as well as those that pertain to the marketing status of generic products. Develops a course of action for the Office response to these petitions. Prepares replies to correspondence from the regulated industry and other interested persons on issues that ar