Hosted By

Isaiah Hankel
Isaiah Hankel
Chief Executive Officer Cheeky Scientist
user experience

Regulatory Affairs can be a hard field to transition into if you don’t have the right information.

Join Isaiah as he interviews Rebba Boswell-Casteel PhD, and gain vital information you need to successfully transition today.

Here’s a quick rundown of this week’s episode…

  • First, Isaiah interviews a few PhDs who’ve successfully transitioned into regulatory affairs positions. 
  • Next, Isaiah and Rebba discuss the current trends in regulatory affairs.
  • Finally, Rebba reveals the 13 essential skills required to transition into regulatory affairs.

From This Week’s Show…

Trends in Regulatory Affairs

I’m very excited about today’s show because we are interviewing Rebba Boswell-Casteel PhD. Rebba is an evidence evaluation manager at Smith and nephew. She is an expert in the regulatory affairs field, as well as the medical affairs. Today we’re talking about regulatory affairs, what the position holds, why PhDs are valued for this position and what skills specifically you need to get into this role.

Your background does not matter, yet as PhD’s we kind of fall back on describing our background just because we’re so used to it in academia. No matter what your background is, you can get into regulatory affairs.

The top skills I will look for are technical writing, cross functional collaboration, and project management.

Science is the malleable component here.

We’ve seen an avalanche of regulations coming out due to the pandemic. A lot of things that needed to be regulated have been exposed because of the pandemic, and regulation is only going to increase.

So, one of the biggest trends that I’ve seen is directly related to the field that I work in – medical devices. Probably five to six years ago, there was no need to write clinical evaluation reports. Now every device getting marketed in Europe is required to have them regardless of classification.

So, regulatory affairs specialists are involved with a product from ideation stages all the way through post-launch. You can’t market a product in any country without having some type of compliance with a federal regulation.

The Essential Skills Required For Regulatory Affairs Positions

Life balance is great. So is job security. There’s always going to be a need to have a regulatory affairs specialist on the team.

In a private company, you represent the company that you work for. And your main point is to make sure you either keep products on the market or gain access to new markets. In the public sector,  your main objective is to make sure that the products that are available in your market or are coming into your market are safe and effective. 

One thing that I particularly look at when I’m interviewing individuals is their adaptability to change. Regulatory is a fast paced environment. It’s constantly changing. 

One of my biggest pet peeves is applying to the company and not knowing anything about it. I’ve had numerous occasions where I’ve received resumes and they’re applying to a position in a pharmaceutical industry. And I work in medical devices. 

If you haven’t interacted with people currently working in regulatory affairs, in this specific case, you are going to struggle. And certainly you’re not going to get hired above those who have.

And the private sector is pretty much a direct hiring approach. The company advertises a position and the company hires you, you can submit just about any type of resume that you want and it’ll get reviewed, whereas in the public sector, there’s a lot of hoops they have to go through. 

So, kind of like I was alluding to in the government agencies, they’ve got their own rules for applications and they have to meet sheer numbers, or they may have a limit for diversity inclusion type hiring practices

We’re trying to show here that networking for a regulatory affairs position in the public sector job is different than the private sector. Of course, the principles are the same. You talk to people about the things that you need to learn about and need to know are specific, not just for agencies in general, but for each specific government agency. 

** for the full podcast, check out the audio player above.

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