11 big ways regulatory affairs has changed in the last 50 years
Regulatory affairs has come a long way.
Our profession landed in the spotlight in 1976 with the founding of RAPS. And while it certainly didn’t happen overnight, regulatory affairs has grown into a respected profession that contributes to innovation across the healthcare field.
Regulatory affairs has transformed from just a job to a profession with myriad career paths (and a community to help you on your way). As the healthcare world has modernized with products that may have sounded like science fiction 50 years ago, the ways these products get to market and remain safe and effective have changed too.
As we look back on RAPS’ 50th Anniversary, we asked our members: what’s one way regulatory affairs has changed in the last 50 years? Here’s what they said.
1. Technological advancements make regulatory affairs less admin and more technical.
“When I started 20 years ago, we were compiling paper dossiers and submissions. We did have early technology allowing us to add electronic page numbers - but not far from the time of a stamp to affix page numbers. The technology advancements have been phenomenal and have really shifted the mix of work from admin to more technical.”
Cate Dillon
Senior Director, Regulatory Affairs
Johnson & Johnson
“The field has transitioned from having limited or unclear regulatory frameworks to well-established guidelines and procedures, with a clear and positive impact on patient safety. I recall my professors describing how eCTD and 510(k) submissions were once prepared as hard copies consisting of thousands of pages physically mailed to the FDA for review. Today, digital submission platforms such as eSTAR represent just one example of how dramatically regulatory affairs has transformed over the past 50 years.”
Rama Doddi
Regulatory Affairs Associate
Cresilon
“When I started working as an auditor for notified bodies, you would visit factories, you would find a regulatory affairs person, and they were hiding in a corner behind quality. And you would know that you had arrived because you would see that the quality offices there were neatly organized with binders everywhere and so on. You came to the regulatory team and papers were everywhere, stacks of paper, regulations, guidance and so on, on their desks. That's how it was back then. By now you will see it's not just one person in that office, but it's starting to be a complete organization within the organization. It's changing and it's so much to deal with globally. All the regulatory changes in more than 80 countries — that takes a big effort of a team, and nobody can really remember everything by heart. So from there, we have moved on to where we are now, where you need also to be able to find the information, you need to work together with people, and you need to have a team to make sure that you can fulfill the global compliance needs.”
Gert Bos
Executive Director and Partner
QServe Group
2. Regulatory affairs is gaining direct influence on a company’s financial health.
“Regulatory affairs has changed from the universal perception of an administrative role to a unit which has a direct influence on the financial health of the company. The exponential growth in the number of regulations and their details as well as the high-profile cases of reported patient harm resulting from problematic healthcare products over the last 50 years has also had a direct influence on the daily work of RA professionals (i.e. definition of preventative measures and structured approach).”
Stephanie Grassman
Managing Director/Founder
MedTechXperts
3. The scope of a regulatory affairs job has expanded.
“The profession has expanded in scope by demanding strategic agility, scientific understanding, and a deep appreciation for ethical innovation. This evolution reminds us that regulatory affairs today is not merely about ensuring compliance; it is about shaping the future of safe, effective, and accessible medical technologies across the globe."
Zakia Alavoodin
Sr. Regulatory Affairs Specialist
Guerbet
4. Companies are being more proactive and less reactive in their regulatory strategy.
"Regulatory affairs has shifted from a reactive, paper-driven function to a global, risk-based system. Though the field is yet to be fully recognized as a business-enabling function, there has been a great deal of 'shift in the mindset' for it to be a science-based discipline. Additionally, fifty years ago, regulations mostly responded to problems after they occurred. Today, RA focuses on prevention, lifecycle safety, international harmonization (IMDRF, ISO standards), and evidence-based oversight."
Heena Thakkar
Founder
Vidyara Training and MedTech Consulting
5. Transforming from “last to know” to key partner status.
“In the last 15 years, I have witnessed the evolution of regulatory affairs from paper-based to electronic processes, and how the specialty has become one of the most critical functions within pharmaceutical companies. I still remember submitting variation dossiers on paper and paying fees in person at the tax center—there was no online option back then. I joined Sanofi in 2014 and have witnessed firsthand the evolution of regulations, submission tools, and internal systems. I have also seen how regulatory affairs has transformed within the organization — from being one of the last stakeholders to consult, to becoming a key partner involved at every stage of a project.”
Houria Lamari
Global Regulatory Strategist
Sanofi
6. A role where the excitement has been amped up.
“From being simply being a paper pushing role to an exciting compliance and market discovery role. We defend the existing product line while looking for opportunities to expand to new indications and geographies.”
Thanga Bhuvanesh
RA/QA Manager
HMT Medizintechnik
7. The pace of guidance is faster.
“I have only been in the regulatory business since 2006, but for sure, the amount of guidance and standard documents has increased tremendously. Devices have always been safe, but they are extremely safe today.”
Arne Jaksch
Managing Partner
Jaksch Lifescience Consulting GmbH
8. In one big way, it hasn’t!
"In a sense, it hasn't changed at all. I feel that despite the progress, the computerized programs etc., we are still busy with the same small issues and tasks, like maintaining TD table of contents in excel, reviewing documents vs templates or even standard/regulations requirements and correcting the same issues over and over.”
Ilia Bing
RA Team Manager
Lumenis Be Ltd.
“This is an answer that will surprise you. Not in the slightest. Not at all. Because back 50 years ago, when RAPS was founded, there were very difficult regulatory issues. FDA didn't have the kind of closeness of working with industry that exists today in order to make things work better. So, regulatory affairs professionals had to work with FDA to find out solutions to problems. Regulatory affairs is nothing other than solving problems, and they do it every day, and they do it extremely well, and they'll continue doing it for the foreseeable future.”
Peter Barton Hutt
Senior Counsel
Covington & Burling
Chief Counsel, FDA (1971-1975)
9. As regulations and products have become more complex, so has the job of the regulatory affairs professional.
“Over the last 50 years, regulatory affairs has evolved from a documenting and compliance fulfilling function into a strategic, technical science-driven discipline today, regulatory affairs operates in a highly complex, globally aligned environment shaped by ICH, risk-based and lifecycle approaches, real-time pharmacovigilance, and increasing reliance on advanced analytics, real-world evidence, and artificial intelligence.”
Shail Shah
Senior Director Regulatory Affairs
Curevo
10. An increased presence in the C-suite.
“We began to see more regulatory professionals wanting to and moving towards more executive roles. The majority of regulatory folks came from a scientific, engineering, or clinical background. So, they don't necessarily have the training in business executive functions that are required, at least, to go and talk to a chief marketing officer, a chief business officer, a CFO, or a CEO. We launched the RAPS Kellogg Executive Development Program to address that. There was an indication that the profession was moving into more influential roles, and that it was influential at the top of the organization.”
Sherry Keramidas
Executive Director (1996-2016)
Regulatory Affairs Professionals Society
11. A march toward harmonization.
"At a global level, regulatory affairs has gradually converged from highly diverse national requirements toward more harmonized frameworks, with the aim of reducing the burden on the global medical device industry — an achievement that is both significant and hard-won."
Silu(Lulu) Zhang
Director of Global Regulatory Affairs
Changchun GeneScience Pharmaceutical Co., Ltd.
Join the discussion on Regulatory Exchange and share your perspective on what’s changed in your daily life as a regulatory professional.