A year in regulatory affairs

My previous industry careers column focused on regulatory affairs jobs in the biotechnology and pharmaceutical sector. Today, I'm diving deeper and getting a firsthand perspective on these kinds of jobs.

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When Kendra Seckinger was an intern at Genentech, she conducted informational interviews to learn about jobs away from the bench.

I talked with Kendra Seckinger, an associate program manager of regulatory affairs at the biotechnology company Genentech in California. Seckinger has been with Genentech for about a year now and started her current position in November. Having just done it herself, she has great advice for scientists looking to stay within industry but transition away from the bench.

From the bench to regulatory affairs

First, a bit about Seckinger. She earned her Ph.D. in toxicology from the University of Maryland, Baltimore, in 2018 and first started working for Genentech through the company's internship program for graduate students. She spent the summer of 2018 working as a lab intern in California before returning to Maryland and finishing her Ph.D.

“It was like a kid in a candy store,” she says. “There were so many resources and really smart people. But I also realized I didn’t see myself staying at the bench long term,” she said.

Since she liked the company, Seckinger took advantage of her time on Genentech’s campus and started setting up informational interviews to learn about other departments and jobs. Based upon conversations she had with people in the regulatory affairs department, she decided to pursue that specialty as a career.

So how did she make the leap? After defending her thesis, Seckinger saw a posting on Genentech’s website about a regulatory affairs internship program. Unlike the lab-based internship she participated in previously, this internship didn’t require applicants to be students, only within two years of graduating. She applied, got a spot, and started the internship in the summer of 2019.

Then, when a posting came up for a full-time job in regulatory affairs, Seckinger applied and landed her current position of associate program manager.

“Not all internships lead to full-time positions,” Seckinger said. “Genentech was upfront and honest about that, but it worked out that I was at the right place at the right time.”

The job, the transition and the perks

Seckinger said that, within Genentech, the regulatory affairs department serves as the bridge between the company and the Food and Drug Administration. Staffers are responsible for setting up meetings with and staying in contact with FDA project managers.

Seckinger estimates there are probably about 200 people in regulatory affairs at Genentech, split into different departments based on their tasks, such as writing and submitting documentation, collecting regulatory intelligence, or formulating strategic plans. At a smaller company, regulatory affairs experts do a variety of those things, so keep that in mind if you’re looking to compare jobs between companies.

Seckinger specifically works in program management, and she said that her team is strategically focused. They help guide the strategy behind the company’s messaging about products or projects, stay on top of project and drug-approval timelines, and work to maintain licenses on drugs that are already approved.

“It was nerve-wracking at first,” she said. “There were a lot of roadblocks in the sense that I was qualified but didn’t really have a lot of experience. There are only so many soft skills you can highlight on your résumé when you spend most of your time at the bench.”

While the transition had its challenges, Seckinger said there have been many upsides to leaving the bench.

“The work–life balance has been wonderful,” she said. “Unlike in graduate school, where I felt like I was constantly working, even at home, I really appreciate that when the workday ends here, work is done for the day. You have so much more ownership of your time and schedule.”

She said there are definitely busy times, but she hasn’t been expected to work around the clock, which was a huge relief after the pressures of graduate school. Another unexpected difference from graduate school was how she was treated when she started.

“People take you seriously,” she said. “As a graduate student, people can often treat you like a child, but here they immediately treated me as a colleague and a professional. The accountability and ownership has been surprising and refreshing.”

Career advice for regulatory affairs jobs

If you think (or know) you’re interested in regulatory affairs jobs in industry, Seckinger had some advice for how you can make the transition. There are specific degrees or programs that focus on regulatory affairs, but, if going back to school isn’t in the cards for you, there are plenty of other options.

Seckinger suggested looking at professional organizations that have certificate programs or continuing-education programs that could help you gain exposure and training. There’s also an examination you can take to become a sanctioned regulatory affairs official; it's called the Regulatory Affairs Certification (RAC) exam.

But, if you want to avoid the formal education route entirely, experience will be your best bet. And Seckinger says that most often means starting at the bottom as an intern, regardless of how much bench experience you have.

“Interning is how you orient yourself with the landscape of the field and learn about regulatory intelligence, how to craft your argument, and other skills critical for the job,” she said.

You might be able to start slightly higher if you have experience in a tangential field, such as clinical trials or medical writing, but if you’re fresh out of graduate school, the best place to start looking is at the intern level.

Timing graduation and your job search may not always be easy, so, if you end up looking for a postdoctoral or other research position to tide you over, you can still prepare yourself for a future career in regulatory affairs. Seckinger suggested looking for investigators with relationships with pharma or biotech companies or looking into a clinical or human subject research position.

“Try to be strategic about where that research position can lead you to and what connections you can make while there,” she said.

If you do happen to land an internship, the good news is that most internships are paid, and, once you land a full-time job, the salary only goes up. Seckinger said that, in the San Francisco Bay area, entry-level salaries start at $70,000 and can go up to $100,000. This salary will, of course, vary across the country and with the size of the company, but they are considerably higher than those of most entry level postdocs positions.

Beyond the salary, Seckinger said, it’s the work itself that drew her in and is what she enjoys the most.

“I just love my job and don’t regret leaving the bench at all,” she said.