The Five Stages of Submissions

Sometimes you've just got to get it off your chest. This article is a humorous take on the regulatory submissions process and the drama it can entail for the regulatory team.

Elisabeth Kübler-Ross identified the five stages of grief as denial, anger, bargaining, depression and acceptance. Regulatory submissions are really no different.

First comes a proposed submission date from management. It is clearly impossible. Surely that is apparent to all involved. It's impossible. Naturally, a typical overworked regulatory professional will enter denial, and continue working on other, more imminent, impossible deadlines and ignore the existence of the Big One.

As the component parts of the submission begin to emerge and meetings become more frequent and shrill, we enter the anger phase. There is no way the group can possibly pull together a submission with the existing data. Data are weak, missing, irrelevant, poorly written, badly organized or have not been properly formatted. Pity the poor, unfortunate writer who used two spaces between sentences during the anger phase. Regulatory professionals can get feisty.

Having alienated our colleagues with our picky insistence on following the rules during the anger phase, the mood shifts as the submission date looms, and we enter the bargainingphase. At this point, regulatory will take any data just to fill in the blanks. We will offer donuts and free formatting in exchange for a report. We may offer gin and a good parking space to anyone who will help collate and bookmark. At this stage, we will rework any previous report, presentation, press release or bathroom stall commentary in an effort to fill up those yawning, empty sections. We may regress to the anger phase to curse writers who didn't include an abstract that we can plagiarize, er…summarize (yeah, summarize). We start to rationalize that requirements are really "just a suggestion" and they didn't mean that we had to comply with all of them…did they?

In the weeks or days just prior to a submission, when no new extensions can be granted, we enter the depressionphase. The regulatory professional is painfully aware of every error, omission and weakness in the submission. It is a steaming pile of hot monkey dung. It will get a Refuse to File or a 23-page deficiency letter. The company will go bankrupt. You will lose your job and you will never find employment again. No, I do not think I'm being overly dramatic, thankyouverymuch. I happen to like it here under my desk in the fetal position. It's quieter here. Please pass my keyboard and carpal tunnel brace.

And then, just before the submission goes in, we magically reach acceptance. This is also known as the screw it stage. A calm descends, and the wise regulatory professional accepts that it is what it is. There is a clear email trail showing you fought the good fight to fix it, but now it's going in.

And it goes.

And we move on to the next thing.

And a few weeks later you get a letter asking for a couple of clarifications that are fairly easy to fix (now that everyone has had some sleep).

And the circle starts again with the next impossible deadline.

About the Author

The author would prefer to remain anonymous (and employed) but wishes to reassure younger colleagues that "'This, too, shall pass.'"

Cite as: Anonymous. "The Five Stages of Submissions." Regulatory Focus. April 2014. Regulatory Affairs Professionals Society.