How can I create a regulatory function that’s a source of competitive advantage?
Many big pharmaceutical companies have responded to increasing regulation by building large regulatory affairs functions and hiring external experts to supplement their internal capability. This can result in considerable complexity and duplication, as well as driving up costs. Although small and mid-sized firms have an advantage over their bigger competitors here, because they are not hampered by large portfolios or complex legacy organisations, they may still have regulatory functions which are very specialist and professional but ultimately disconnected from the business. Any company wanting to create a regulatory function that is a source of competitive advantage rather than spiralling costs should start by ensuring that it understands the real drivers of complexity. Pragmatic balance between central control and local autonomy to enable staff to cultivate good relationships with the authorities in their respective territories is essential, as are appropriate measures to track the e
