To get started, do you want to tell me a little bit about your background?
I went to a college preparatory high school. It's like a college where you have to declare a major in high school, and mine was chemistry and biology because I wanted to become an anesthesiologist. And that didn't quite work out, so I went to law school. And I always had, in my mind, wanted to marry the two, like, “How do I rejoin the community?”
After law school, I was asked to help a medical device firm with an intellectual property matter. While there, the Canadian CEO says, “I need someone to do regulatory for me,” And I said, “Okay. What is it?” Didn’t even know what it was, right?
The FDA had an industry phone line that, if you had questions, they could give non-binding guidance as to how to meet the regulations. So, I pretty much learned how to do my regulatory strategy job in devices from the FDA and trial and error. At some point, I saw how many television commercials about drugs were starting to come online, and I thought, “This is going to be a huge area of enforcement for the health industry. How do I get from where I am now to where that’s all happening?” Which was really on the drug side.
Through a series of moves that led me from devices to drug delivery devices, I finally got an opportunity to join a company’s labeling group. That group often gave guidance and advice to the advertising and promotion group, because the world of pharmaceutical drug promotion is driven by the label and what can be said based on what’s on that label.
From that company, I moved to another company and fully into advertising and promotional biologics and pharmaceutical drugs. So, it took a series of about 10 years to get from regulatory strategy for medical devices to doing a very niche-focused, targeted advertising and promotional review of pharmaceutical drug materials.
How do you feel about working in Regulatory Affairs? What’s it like?
Well, that question gets the typical Regulatory answer, and that answer is it depends. It depends on what part of the regulatory process you’re in, and what type of company you’re in. For instance, when I was in medical devices, I had the full gamut of Regulatory Affairs responsibilities for a product from their R&D and working with clinical and engineering colleagues, to helping write the submission to the FDA and creating promotional tactics to market, promote, and sell the drug. If you’re in a large pharmaceutical company, you probably have a very discreet single role that covers a piece of the things I just listed out.
But to answer your question, it’s what you want to make it. Do you want to have more than a single responsibility to execute on? Or are you the type of person who likes a broad set of roles and responsibilities that broaden your career and trajectory? You can do more than one thing. In my case, coming into pharmaceutical drugs through a very narrow pathway of promo, it’s been incumbent upon me to keep learning in this space.
Over your career, what have you found to be the most useful skills a professional can have?
You need to bring your whole self to a Regulatory Affairs role, because it covers every single operation in a medical device firm. And when I say that, it even goes down to the custodial services. If you’re manufacturing in an unclean space, that could be a regulatory issue. It really is good to have knowledge of science, technology, and policy. You should have excellent research skills, great writing skills, and interpretation skills.
It's about what role you’re going to have. Are you working with chemistry, manufacturing, and controls? Then you need to have a good sense of acceptance criteria, standards for producing the product, evaluating, testing, and record keeping. Anything that supports the good processes of putting a product to market that can be sustained and repeated with expected results of efficacy.
If someone wants to work in Regulatory Affairs, are there any certifications or courses you would suggest they take?
There are a growing number of universities from California to Boston, and online Masters-level certifications for Regulatory Affairs professionals. RAPS offers what they call the RAC, I would suggest any of these. However, I don’t think anything can beat on-the-job training. The truth of the matter is, because some of these things are so new, you’re going to always learn on the job. Sometimes you are creating something for the first time, and you really don’t have anywhere else to look for guidance because you’re the one paving the road ahead. As the industry moves forward and technologies develop and advance, you’re going to always be braced to adapt.
Other sources, like the FDA, also host webinars and have video training on YouTube for certain aspects, like explaining how they see industry meetings and their requirements for meeting the regulations. The regulations themselves are a source of training and learning. You don’t have to go anywhere; all you have to do is get your hands on the regulations. The issue comes with how you interpret and execute your interpretation of what the regulations are saying they require of you, and that’s where experience comes in.
What is Regulatory Intelligence? How is it used?
That can be public and non-public information. It’s usually public information collated and curated to inform product design and clinical trial design. You can use it to develop strategies in your clinical development programs or how you approach a policy decision, whether you want to push back on a new interpretation of a guidance document the FDA is publishing, and so on.
Is Regulatory Affairs a good career field? How would you describe, would you attempt to find another job on your own?
I would say it is. You can enter at a level of learning, and you can end up a vice president of a Regulatory Affairs group. I’ve seen that happen to people, and it’s happening to people at a much younger age now.
It’s very common, with tools like LinkedIn, to do your own searching, right? And then, as your career moves up the ladder, it’s more about who you know, who’s worked with you, and do they want to bring you up under their fold to continue working with you. I find that, at some point, when I feel my own initiatives and activities are not netting what I’m hoping for, I will consider engaging with an executive search firm like Brandon’s.
How did you and Brandan meet?
I was working at a firm in Cambridge, Massachusetts, and that firm had been acquired by a larger French-European company. They were doing business with another smaller third-party company in another state, and there was an opportunity for Brandan to position me with a company that would bridge those three companies. I took that opportunity, and I kept his number ever since.
I don’t know that I view Brandan as a recruiter anymore, because he rises above the rest in that respect. You’ve got recruiters who will call you up, tell you they have something, ask you for your resume, and you never hear from them again. All they’re doing is utilizing your resume to embellish the pool of candidates they put in front of their clients. I see Brandan as more of a lifestyle matchmaker. He is really trying to work with me in such a way that we make the right fit. Selection and decision, not just for me but also for his firm client, that we match personalities and morals and ethics. Because when you arrive in an executive career trajectory, you are working with people so closely that you need to be on the same page to get things done.
He's very knowledgeable about the industry itself. That’s another level of care and consideration I feel I’ll get working with Brandan versus some of the recruiters that are out there. I really feel he gets my loyalty due to his high level of client engagement and his knowledge of science, technology, and how to match personalities with corporate environments.
Have you encountered any roadblocks as a woman in biotech Regulatory Affairs?
I would have to say of course I have, and probably many I don’t know of. Some are consciously observable. But it’s about the fight in me as well. I saw a career path I wanted. I was not necessarily scientifically trained for it, but what I did was marketed myself. I had the roadblock of being a lawyer trying to do a science job, so I sold myself as having transferable skills with my law background.
As a Black woman, there’s always that level of challenge. It’s just the American society and how we operate, and I’ll look forward to the day when that doesn’t matter anymore. You’re going to always have hurdles in any industry, and you have to be good at what you do and work well with others. The rule books may not all fall away, but they melt down.
What would you say your biggest challenge has been?
Well again, back to technology and science, there are always new IT tools to adjust to. If the company has decided to invest in a certain tool, how do you get your hands on the necessary learnings to be a part of that? Do you have to go to a university course? Can you go to a professional conference, or can you be self-taught? That’s always a big challenge, staying current with science and technology. It’s good to come to Regulatory Affairs with the entrepreneurial spirit even if you’re in a huge Regulatory department, because the more self-driven and passionate you are about it, the more you’re going to want to build your skillset out.
What do you see coming down the road in the next 5 to 10 years?
Well, I wish I could tell you what the future holds. But I can say in the pharmaceutical space I currently live in, a lot of changes were implemented on-the-go because of COVID-19. So you’ll probably see changes in the way clinical trials are monitored. The FDA has put forth a guidance document for increasing diversity in clinical trials. The switch to using more real-world data and evidence to get product approvals, so that trial sizes might be reduced because the heavy cost burdens companies and the data doesn’t always net out… That may be seen more and more as part of the new wave. And then, we don’t even know what’s coming, right? Somebody’s going to go into a laboratory, make something new, and then we’ll have to adapt.
Learn more about Gibbs Pharma Solutions’ work in the pharmaceutical regulatory training field and hear from prior clients about how ERAPS matched them with their ideal job.
