Regulatory Affairs Involves much more than the ability to recite from the CFR guidelines. As critical members of the strategic development team, we assess the company’s needs and balance them against constantly changing regulations and interpretation of regulations, medical need and changing medical practice, precedence set by other products under development, and worldwide registration plans. The product development strategy changes as the landscape changes. Sources of new information include regulations, guidelines, success/failure/precedence from other companies or their own company, agency websites, press releases, professional meetings and training courses, industry newssheets and publications, and other colleagues.
This flood of information must be constantly looked at from different angles and assessed for potential impact; making experience very important component. Regulatory can only function successfully if there is free access to information and no one else deciding what information should go to Regulatory Affairs. It is a critical regulatory function to understand how all of the disciplines are interconnected and how one change can cascade into other areas.
For example, a plan to conduct pediatric studies earlier in the program means more than having adequate clinical resources and drug supplies. It could take a year or more for the other functional areas to be able to support the trial. For example: non-clinical (juvenile toxicity trials), CMC (adequate supplies, pediatric formulation, new drug product manufacturer, potential need for QP release, validation, shipping, packaging), Biopharmaceuticals (dosing information, PK data), and Regulatory Affairs (negotiation of pediatric plans with regulatory agencies).
Successful regulatory experts also understand the target audience for the information. In this difficult financing landscape, the target audience is often not just the FDA or other regulatory agency. Instead, there could be a need to explain the strategy to the financial community and the strategic plan is targeted to reach a financial milestone and not necessarily a concurrent FDA milestone. It is also important to understand the available resources for a project as more and more companies, large or small, work in the virtual environment and project team members are spread out across the world. A successful regulatory strategist, most of all, must remain flexible.