As regulatory affairs groups in the pharma industry continue their shift into more strategic roles with greater influence on product development, it is vital that these groups are structured efficiently and communicate well both internally and externally. Successful regulatory groups build on clear organizational structure, cross-department coordination and strong regulatory agency communication.
#1: Global regulatory groups need to be positioned as a resource for country-level operations.
#2: Making sure that other parts of the company understand agency requirements will avoid unnecessary regulatory delays for future products.
#3: Keep agencies well informed about upcoming and current products so they fully understand the benefits of the therapy.
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