Experiences at TAP Pharmaceutical Products Inc. (TAP)

* 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...