So, suffice it to say, I am approaching 50 years old and thus have never blogged before, but the idea was planted last year at an industry award dinner when I was seated at a table with the award winning blogger, who blogged about fashion, and was about my age. So, I figured (as I have with everything from regulatory submissions to parenting), if she can do it so can I!

Here goes . . . who am I?

Well, as I already mentioned, I am an almost 50 year old female, married with two amazing daughters, a regulatory affairs professional whose primary job is to create and help others create regulatory filings for new drugs. I have spent the better part of 23 years doing the latter. I am almost at the tipping point (great book btw) for having done this in my life more than everything else combined. I measured my marriage like that and am now, being married 26 years on the “other side” as I got married at 24.

My future blogs will be more regulatory in nature, I promise, although I honestly am not sure how far and in which direction that will be. But, for this first one I wanted to share a thought that came to me this weekend.

And the subject is: Regulatory professionals and wine!

I was reading, finishing actually, Susan Sokol Blosser’s autobiographical book about starting a winery. It was a Christmas gift from my younger daughter, who knows I daydream about such a career change. The book was an eye-opener about the realities of wine life, but made me realize that the same things that make someone a great vineyard/winery owner are what make a great regulatory person. Apparently, I am not the first to surmise this, as in my own small circle of regulatory acquaintances, there are 3 people already realizing MY DREAM!

So what are these crossovers (in no particular order): commitment to quality, attention to detail, understanding of process and incredible work ethic! These qualities can be measured and actually tasted in the world of wine, but they are harder to see in the drug development world, but if you look closely you will see . . .

Commitment to Quality is not just some grouping of words that justified a committee or corporate program in the 80’s, it is really putting out there your best effort and not settling for anything less from others. In the regulatory world that means that you hold the science sacrosanct and let the data speak for itself all the while presenting it in the best most efficient way. You make sure all your boxes are ticked, but then go beyond that to make sure that what you are saying is true, complete and concise.

Hand in hand with that is attention to detail. I am blessed with a great group of fellow regulatory professionals, who all have a touch of OCD (Obsessive Compulsive Disorder). It is who we are and why we are good at our jobs. We don’t just check something once, we check again and again and drill down to the detail everytime we review, much to the chagrin of those around us. We rely on our process, but not more than on ourselves and on each other, to ensure consistency. Consistency is something we crave more than anything else and we work hard to create it. We look for it in how we clean our houses, or pack our bags or organize submissions.

Finally, we work hard! Not just in hours but in intensity. Regulatory people are intense, we admit it. It also is what makes us good at our jobs.

Did I mention we also play hard? Well, back to that wine I was writing about . . .