If you found your way to this post, then you’re either here because you’re searching for a lucrative career, or you have no idea what regulatory affairs is and you’re curious. Either way, you’re in the right place!
Regulatory Affairs is an amazing, rewarding career path, especially for those with a science background. There’s few resources available online for those seeking to enter into regulatory affairs, so we’re here to help you see if this is the right career for you.
INTRODUCTION
“So, what do you do for a living?”
Ah, my favorite, least-favorite question I’m always asked (right behind, “When are you having kids?”). It’s not that I hate what I do or feel ashamed about it; it’s just that, when I say, “I’m a regulatory affairs professional,” I usually get that confused, what-the-heck-is-that look…
That is, unless the person thinks they know what regulatory affairs is. That’s when things get entertaining because they usually think it means I’m some sort of lawyer.
Nope, I’m not a lawyer.
But I am pretty good at reading people, so when I see the what-the-heck-is-that look on someone’s face, I try to throw out some buzzwords to see if anything sticks. “I work in the pharmaceutical industry,” I say, thinking it’s specific enough to give the person an idea of what I do, but broad enough to deflect any additional questions.
Doesn’t work.
When someone hears “pharmaceutical”, they think:
- You’re some “big pharma” money hungry business person whose mission is to hurt everyone in the world and give them prescription drugs they don’t need.
- You’re a mad scientist in a wet lab creating dangerous things that will take over the world.
- You’re a pharmacist.
- You’re a pharmaceutical sales representative.
I’m none of those things.
By this point I’m usually just as exhausted in trying to describe what I do, as the person is trying to figure it out! Who knew careers could be so complicated?
But really though—what is regulatory affairs?
WHAT IS REGULATORY AFFAIRS?
Okay, the question of the hour. What the heck is regulatory affairs anyway?
My quick, 1-second pitch for what I do: I get drugs approved.
BAM! Pretty boss, right? I think so anyway…
Regulatory Affairs sits at the intersection between science, business, and law, intertwining the three disciplines together into one. The overall goal for any regulatory professional is to demonstrate the safety, tolerability, and effectiveness of a drug to a country’s health agency (e.g. FDA, MHRA, EMA, etc.). In other words, a regulatory professional works toward getting a drug approved and maintaining the life cycle of the drug post-approval.
I’ve heard regulatory affairs professionals described as the liaison between a company and a health agency, or a conductor within the company, orchestrating things between various team members to put together an “award winning” (i.e. approvable) drug application. Regulatory affairs professionals play an integral role in the success of any pharmaceutical company. Without a strategic regulatory department, you ultimately won’t have solid products within a company’s pipeline; and without products in the pipeline, you don’t really have a company…
WHAT DOES A TYPICAL DAY LOOK LIKE?
We like to say that working in regulatory affairs means working in cycles, kind of like a sine wave (remember those?). There are days that are super busy and can be stressful as you try to adhere to tight health agency timelines and hit corporate goals. Then there’s other days where you’re reading through regulations or reviewing documents and it can all seem a bit slow or mundane. But the good news is, since you know you’re on a sine wave, you know things won’t always be the way they are. You learn to adapt to changes quickly and appreciate the stage of the process that you’re in.
A typical day for a regulatory professional will look different depending on the position, the company, and the product. For instance, more junior professionals (associates) spend their time learning the basics and working on drafting cover letters and forms and putting together simple submissions to health agencies. More senior positions tend to do more strategizing and complex submissions.
For me personally, a typical day involves the following to varying degrees:
- Meetings with cross functional team members to strategize and discuss submissions or clinical trial management
- Regulatory research (i.e. looking up regulations on different topics, synthesizing the information, and using it to strategize an approach that can be applied to our product)
- Drafting and reviewing major documents (e.g. Investigator’s Brochure, IMPD, Protocol, Annual Reports, etc.)
- Putting together submissions
This is an incredibly high level and rather trivialized overview of what I do. If you want a better idea of what regulatory professionals do, I recommend looking up some job descriptions on LinkedIn.
WHAT SKILLS DO I NEED FOR A CAREER IN REGULATORY?
While there are some technical skills that you’ll need for a career in regulatory, most of the technical skills can be learned over time and taught on the job.
Usually, when someone is hiring for a position in regulatory, they’re looking at whether the person has the right soft skills to handle the position.
The type of soft skills needed for a successful career in regulatory can depend on the company you’re working for. There is one company I have interviewed with where I was asked multiple times how I handle stress and assertive personalities…(Yikes!) Overall though, here are some important soft skills that you need for a career in regulatory:
- Communication: This is probably the most important skill in a regulatory career. You have to be a strong communicator, whether you’re speaking with health agencies or cross functional colleagues, or you’re writing correspondences. Communication is really at the core of what we do.
- Leadership: Considering regulatory professionals are like the “liaisons” or “conductors” in a company, it’s important to have the leadership abilities to work well with other functional groups and to stay on top of tight deadlines. Other functions will look to you for guidance and advice, so you’ll want to make sure you can steer the team in the right direction.
- Time Management: As mentioned above, regulatory tends to go in cycles—one day you’re swamped with work and trying to hit deadlines, while the next day you have time to brush up on the latest guidances. You have to know how to use your time wisely and adjust your workload depending on changing priorities.
- Organization/Planning Skills: All of the submissions you make take organization and planning, especially when you have to do a number of major submissions at the same time. You have to get very good at organizing and planning things out in advance because most of what you do will require cross-functional team input or review.
Of course, these are not the only soft skills you need for a career in regulatory, but they’re a great start.
DO I NEED A SPECIAL DEGREE OR CERTIFICATION?
Photo by Will Barkoff on Unsplash
Great question–it depends on the country. Most countries will require a “relevant” Bachelor’s degree (i.e. a Bachelor’s degree in a science field) at the very minimum. Some countries are more specific and require you to have a pharmacy degree in order to enter into the field. So depending on your country, take a look at a few job descriptions and their requirements to determine if you qualify.
In the United States, there is no requirement to have a particular graduate degree to enter the field. You can enter the field with “just” a Bachelor’s degree in a scientific field. If there is a requirement for a graduate degree (Master’s, PhD, PharmD, etc.), it’s most likely a company requirement, as opposed to an industry requirement.
That said, there’s a new, unspoken trend that’s been permeating in the last few years. It’s becoming more common that people will enter the field with a certificate or Master’s in Regulatory Affairs, or they’ll have their Regulatory Affairs Certification (RAC). This is not a must to obtain a regulatory affairs position. From my experience, most employers are looking for your experience in regulatory affairs or something relevant–not whether you can regurgitate the regulations based off what you learned in a program. If you do not have any experience in regulatory, then employers are typically looking for soft skills, such as the ones mentioned in the section above.
HOW CAN I GET A JOB IN REGULATORY AFFAIRS?
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Finding a job in regulatory affairs is similar to finding a corporate job in any industry—it takes persistence and going after it.
If you don’t have regulatory experience and you want to get a job in this field, it’d be best to look for internships, temporary, or contract positions first, in order to “get your feet wet” and see if this career is really for you.
Also, from my experience, employers will tend to hire interns, temps, and contractors for full time positions later on. These types of positions are literally just a way to get your foot in the door, so don’t dismiss them just because they’re not full time.
The other way to land a job in regulatory is through networking. Honestly, this may be the best, most effective way to find a position, and it was the way that I actually found my way into the industry. If you have a friend or colleague who works in regulatory affairs, check in with them and see if they have any positions open that you can apply for.
OK, HOW LUCRATIVE IS IT (AVERAGE SALARY)?
Salaries generally vary based on position level and the city you’re in. Obviously, the cost of living in a major city like San Francisco or New York will yield a higher salary than living in a more rural city.
That said, a 2018 Compensation Survey of Regulatory Professionals conducted by RAPS found that the “median total compensation for US-based professionals ranges from $93,000 for associates to $256,500 for vice presidents.”
Yup, regulatory is a pretty lucrative career!
WHERE CAN I LEARN MORE?
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[Note: The links below are not affiliate links. I do not receive a commission or anything from referring to these organizations. I simply think these are the best resources for anyone looking to learn more about regulatory affairs.]
The main regulatory resource available is the Regulatory Affairs Professional Society (RAPS). They have a message board where you can communicate with other regulatory professionals. They have a lot of literature based resources and articles that you can learn from. They also host annual conferences that regulatory professionals attend which is also great for networking.
There’s also TOPRA—The Organisation for Professionals in Regulatory Affairs, a European based organization. It’s similar to RAPS with a focus on European regulations.
If you want to learn more about working in regulatory affairs, feel free to reach out to me directly! Leave a message in the comments or visit my contact page.
WHY IS REGULATORY AFFAIRS SO COOL?
I mean, who doesn’t want to say they get drugs approved for a living?!
In all seriousness though, regulatory affairs is pretty cool because it’s a multifaceted career where you can change the lives of people forever. It can be hard to see that when you’re swamped in the day to day tasks, but once you get that drug approved, it’s one of the greatest victories ever in your career. Think about rare diseases or various cancers. Not every drug works for every person, but that new drug that you helped get approved may be the drug that actually works for someone.
If you’re interested in regulatory affairs or have any questions, I’m more than happy to answer them–so comment down below!
