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Global Regulatory Affairs (GRA) is organized into the following functional groups:
- Therapeutic Customer Channels (North America, Europe, Most of World)
- Global Chemistry, Manufacturing and Controls (CMC)
- Global Labeling
- Global Promotion
- U.S. Regulatory Liaison and Policy
- Operations
In partnership with Regulatory Affairs colleagues in our country
operations, GRA provides regulatory expertise and strategic guidance
in all aspects of drug development, commercialization and post-marketing
processes.
This includes:
- Development of first-in-class, globally aligned regulatory strategies,
including proactive planning and forecasting, facilitating the
preparation of drug dossiers that meet the needs of our global
markets
- Establishing strong, transparent and collaborative relationships with our health authorities
- Positioning ourselves to influence the external regulatory environment
Global Regulatory Affairs colleagues are integral
members of key development and promotional teams throughout Schering-Plough
driving global regulatory alignment for the strategy and content
of key submission milestones and deliverables. As part of the SPRI
Global Development Organization, GRA colleagues collaborate with
colleagues in Global Development, Global Quality, Global Supply
Chain and the Global Pharmaceutical Business units to ensure the
production of high-quality, competitive drug dossiers and pre/post-marketing
submissions including development of competitive 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 review and approvals.
Global Regulatory Affairs and our country operations regulatory
colleagues are the primary face of Schering-Plough to our regulatory
customers 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 our
regulators is essential in advancing our drug development programs,
securing first-cycle approvals and facilitating timely product introduction
to the marketplace.
Building upon the strong and transparent relationships between GRA colleagues and health authorities, they are positioned to proactively engage with our external customers to shape the future of the regulatory landscape and to proactively anticipate and assist the company in reacting to upcoming changes that may impact our programs and products.
Moving forward, the Global Regulatory Affairs community will continue
to enhance its capabilities to function as a single high-performing
regulatory engine, standardizing on processes and enabling tighter
and more meaningful collaboration across the globe.
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