How regulatory writing can help you transition into a regulatory affairs career

Regulatory writers translate data, documents, and deep knowledge from subject-matter experts into submissions that support the authorization of safe and effective healthcare products by national regulatory authorities — and get them into the hands of patients who need them.

Regulatory writing can be someone’s first real exposure to the regulatory process — and it’s a skill that involves so much more than its name conveys.

“Regulatory writing is a group endeavor,” writes Lisa DeTora, editor of the recently released Regulatory Writing: An Overview, Third Edition, in the book’s foreword, “and its authors, contributors, and reviewers work conditions that can vary widely.”

DeTora, a professor of writing studies and rhetoric at Hofstra University, has served as editor of all three editions of the book. She and Jennifer Grodberg, a contributor to all three editions, sat down with RAPS to discuss the new book, regulatory writing in the age of AI, how the discipline can serve as an entry point into a regulatory career, and more. Their comments have been edited and condensed for clarity. 

How can regulatory writing help someone transition into regulatory affairs?

Jennifer Grodberg: Regulatory writing is a great entry point for folks who want to move into other aspects of the regulatory field. I regularly mention this book to individuals who are considering entering regulatory affairs, especially to scientists who are generating the bioloigcal data that is incorporated into various regulatory documents. Through helping to draft nonclinical reports or summaries of their work, it's a great way of learning more about what goes into regulatory submissions as a whole. In fact, I had a call earlier this week with somebody who's been a bench scientist and is thinking about moving into regulatory affairs. If you're already starting to work on some documents, continue along that path. This book can help you look at the wider range of regulatory documents that are out there. There might be an area of regulatory affairs that resonates with you. 

What do you think is appealing about regulatory writing or regulatory documentation, either as a main job function or as part of your role?

Lisa DeTora: Many jobs that include regulatory writing. Regulatory affairs, regulatory coordination, regulatory operations. There are also forms of regulatory documentation and publication writing, and medical writing, across many different areas.

One thing I think is attractive about regulatory documentation is the teamwork element. You're working together with a team of people to forward an aim that is helping human health. It's meaningful work, even if the day-to-day has some elements that are a little bit tedious.

Of course, the answer to "what's attractive about regulatory writing" is going to be different for everyone. This book has 26 different authors, and each of these different voices provides more information that could help the reader. No one perspective is enough to really convey what regulatory writing entails.

For somebody looking to get into more of a documentation role, or an operations role, or a regulatory affairs role, or needing to work with people in those capacities, this book provides insight for all of those different areas.

You’ve each been involved in all three editions of this book. What’s changed about this book as you’ve updated it?

DeTora: First, the regulatory frameworks themselves have changed a lot. And with the advent of different regulations about things like combination products,  and the new availability of mRNA vaccines, and the EU Clinical Trial Information System, I mean, these are huge developments that impact the work that people need to do, but also the framework within which people are doing that work.

The material conditions of regulatory documentation have changed as well. If we are thinking about AI now, we've been thinking for a long time about automating narratives. It used to be a job as a medical writer was to sit down with these giant piles of paper and type out these narratives. The whole character of that job has changed. With AI and other technological advancements, many of the more unpleasant parts of regulatory documentation have been converted into more mechanized tasks. These days, it's more just doing the double-checking step, as opposed to typing it out and making all the mistakes, and then double-checking it.

Grodberg: The other thing that I've noted over the course of time, is the requirement for a lot more layperson-style writing for public-facing documents. You still have the fundamental facts there — it's how you're presenting them. There's always been a layperson audience to a limited extent, for example prospective clinical trial participants who review the informed consent form. But now there additional clinical document elements such as protocol synopses and slinical study summaries that are public-facing, both to raise awareness and for transparency. That's taking it to another level of diversifying the writing work product.

Regulatory Writing: An Overview, Third Edition offers a practical, experience-based guide to the purpose, preparation, and review of regulatory documentation across the product lifecycle. It is available in print and as a searchable e-book or e-book subscription in RAPS Library.