Global Regulatory Affairs

Global Regulatory Affairs (GRA) provides regulatory expertise and strategic guidance in all aspects of drug development, commercialization and post-marketing processes. This group is the liaison between SPRI and regulatory agencies worldwide (including the U.S. Food and Drug Administration, the EMEA in Europe, PMDA in Japan and health authorities in all Schering-Plough markets). Building strong relationships with regulators is essential in advancing drug development programs, securing first-cycle approvals and facilitating timely product introductions to the marketplace.

One of the main goals of GRA is to ensure the production of high-quality drug dossiers and pre/post-marketing submissions, including development of appropriate labeling and promotional materials. The end result is the development of drug dossiers that are in compliance with corporate and regulatory standards leading to expeditious reviews and approvals.