September 24, 2021
After joining Cepheid as the International Regulatory Affairs team’s first intern, Anisha Panth quickly found herself in a full-time role—and she hasn’t stopped learning since. Below, she shares the challenges and opportunities that come with working in a fast-moving field within a fast-growing company and explains how she’s helping to pave the way for those who come after her, within Cepheid and beyond.
I cover Southeast Asia, Japan, and Australia for our International Regulatory Affairs team—we work with the authorities in each country to make sure they have the information they need to approve Cepheid products. Essentially, it’s our job to show that our test kits are safe and effective. That usually starts with compiling a submission dossier that has our package inserts along with detailed analytical and clinical reports, along with country-specific requirements. Then regulatory authorities will come back to us with any questions they have. Often, we need to reach out to other teams here at Cepheid for the answers, so we do a lot of cross-functional work, especially with R&D, Quality, and Product Transfer. We also collaborate closely with our Regulatory Affairs teammates in the U.S., who have a lot of detailed insight because they’ve already launched the product there.
The way we work differs from country to country. Sometimes we don’t have a local office, but we do have a distributor who acts as an intermediary. In other places, like Australia, we work directly with the regulatory authority. The pace of our work also varies depending on the location. From some places, like South Korea, we’re getting new questions every day. Others might reach out just a couple of times per month.
I was initially introduced to regulatory affairs when I was in New Zealand, studying for my master’s in pharmaceutical sciences; it was part of our core curriculum. At the time, I wanted to work in the lab. But I have a wrist injury that eventually made that too difficult, and I liked the idea of getting closer to patients—even the best product isn’t much good to people if it’s sitting on the shelf. One of my main research topics, for example, was pain management after knee replacement, and our idea was to inject microparticles that would allow patients to start physical therapy more quickly. At first, I assumed we could be helping patients within two or three years. But I realized there’s so much more involved in bringing a product to market, including regulatory work, which I find so interesting. Every country is different, and things are constantly changing. You really have to be on your toes.
After I finished my degree, I moved to the U.S. and did a second master’s in medical product development management with a focus on regulatory affairs. One of my professors, Sowmya Arunkumar, is also the Senior Director of International Regulatory Affairs here at Cepheid. I first joined as an intern on her team. My mentor, Sruti Krishna, handled Southeast Asia at the time, and I took on some of her responsibilities.
She’d trained me well and had been good about documentation, plus the team was very supportive. It went well, and when my internship was over, I was offered a full-time position. That was almost four years ago, and I’ve since been able to move into more senior positions twice, still as a regulatory affairs specialist. And I’m working with Sruti again—she’s currently on the U.S. regulatory affairs team, and I shadow her on one of her core teams working on regulatory affairs for a new product launch.
Sometimes the questions we get from regulators are vague or difficult to understand, and the guidance they offer can be ambiguous. So, there’s some trial and error. But there are also a lot of resources, whether it’s training or guidance online, or just asking your manager for help. And once you finally figure something out, it’s so satisfying!
There’s also a lot to keep up with in regulatory affairs, which I think is especially hard when you’re new to the field. Regulations are constantly changing, but you do get used to that. Management also provides a lot of tools to help. We have access to a global database called Tarius, and our partners from other teams will come in to educate us and give us a more in-depth understanding of their work.
For me personally, time management has been a challenge. On top of my usual responsibilities, I might be covering for an open role or someone who’s on leave, and I always want to balance the day-to-day with learning new things. But I’m in a mentorship program that’s given me some tools for prioritizing and even delegating, and my manager really helps, too. I have had times when I felt like I was working at every opportunity, but that was because I wanted to—our team is actually very flexible.
While something like COVID-19 obviously requires adaptation, our managers are very understanding of our boundaries. For example, I just got a puppy, so I’ve blocked time on my calendar for training him. Cepheid has grown a lot since I joined four years ago, but I still feel like management is understanding of our needs.
My first couple of years here, I was working toward my global certification from the Regulatory Affairs Professionals Society (RAPS). Preparing for the exam takes a lot of time; thankfully, my manager Ting Chen and my entire team were very supportive. And I do think getting certified has made me better at my job; when you understand the background and history behind a regulation, it’s much easier to interpret the current guidance. A lot of the regulations in Southeast Asia, for example, are based on the ones in the U.S. and EU. The more educated you are, the easier it is to quickly find the answer when a teammate comes to you with a question.
And even though I’ve earned my certification, continuing education is still critical in our field. Whenever I see something new, I like to dig into it. Our team has “no-meeting Fridays” every week, so we can focus on building regulatory intelligence. Management definitely understands that there’s new guidance out every day, and it’s important that we keep up to date.
Very fast-paced, especially at the beginning. Obviously, this was an unprecedented situation, so the regulatory authorities were adapting in real-time, coming up with new requirements—and we had to adapt along with them. We were constantly on watch to see what guidance they were releasing, and that was exhausting at times. But it was a great learning experience. Of course, each country wanted to move as quickly as possible, and they worked closely with us to expedite approvals. In a place like Singapore, for example, where it would normally take about a year to approve a test kit, we were able to do it within a week or two.
For me, the big takeaway was that we should be working toward more harmonization between countries. We’re often providing very similar documentation to each and standardizing that could make a big difference in an urgent situation like COVID-19. There have been some efforts toward that in the industry over the years, and I’m looking at how our team might be able to get involved.
The teaching was at San Jose State University, where I studied with Sowmya. She asked me last year if I’d be interested in helping her update her curriculum to align with recent regulations. That was another great learning experience because I was reading so much, from so many different countries. I also got to add some things that I thought would help the students. And I learned a lot from their questions, too! Sometimes it’s really tough to find the answer, and you have to do a deep dive.
The mentoring is here at Cepheid, working with people in our internship program. Because I was an intern myself, I wanted to give back once I had a few years of experience and felt like I was ready. It’s also been an opportunity to see what some aspects of people management look like, in case I want to explore that at some point.
Because of the pandemic, the entire internship program was remote, and I couldn’t just stop by my mentee’s desk. But we adapted pretty quickly. We met every morning to talk about what she was working on—and even a bit of our lives outside work. She had a great attitude, and I really enjoyed it.
In the short term, I just started working with Australia a couple of months ago, so I’m excited to learn more about their regulations. Our team also supports our Regulatory Affairs colleagues across other regions as new regulations take effect, and I’m looking forward to helping out with that, too. Down the road, I do think people management is something I’d like to explore, and there’s certainly lots of opportunity at Cepheid; we’re growing so quickly. But I have some things to learn before I get to that point. Right now, I want to focus on just being as good at regulatory affairs as I can.
Ultimately, my goal is to be an expert—a one-stop shop when someone has regulatory questions. And when they’re facing a challenge, I want to be someone who can help come up with a solution.
In a lot of companies, regulations are sometimes seen as a hurdle because there are a lot of requirements to meet. But I think we can have much more value as partners, working with our colleagues to get products to patients as quickly as possible.