ABSTRACT
There are numerous texts (including this one), journals, Websites, conferences, and professional societies devoted to the regulation of drugs, biolog-ics, and devices and interpretations thereof, but very few writings that speak generally to survival and success in the profession of regulatory affairs. While there are several academic centers providing graduate and certificate training in regulatory affairs, these too focus on the hardware of the matter: the laws, regulations, science, technology, and ethics of product development/marketing/regulation. What’s missing? The real “fun” stuff consists of those unseen connections between all of these spheres and the balancing act of the persons who manage the connections. It’s fine to know all the laws and regulations by heart (I don’t, not even the regulations most applicable to my area!), but what really counts is an ability to interpret and connect, and to adapt this ability based on circumstances. This is what separates regulation professionals from regulatory professionals. This chapter is an attempt (albeit limited by scope and the author’s expertise) to discuss the practice of regulatory affairs-the fundamental tools of the trade, without resorting to specific products or classes of products. The chapter is organized in a way that moves us from the most general of concepts toward the most practical. We need to start figuring out what is actually meant by regulatory affairs, then work from basics like education and attitude, through communications and documentation, and finally end with submissions.
