Shail Shah on mitigating regulatory risks and 'the one-stop shop for all things regulatory'

Shail Shah is the director of regulatory affairs with Curevo Vaccine. Shail spoke with RAPS about mitigating regulatory risks, transitioning from manufacturing to regulatory, and what he sees as the top benefits of attending RAPS Convergence. This conversation has been lightly edited for clarity.

Tell us about your current role.

So, currently I'm working at Curevo Vaccine as director of regulatory affairs. I head the department, and my role is to strategize as well as oversee day-to-day regulatory operations and submissions. I interact with CMC, quality, clinical, and basically make sure that I take the company's overall business point of view and evaluate risk. I make sure I’m always factoring risk into the equation and mitigating those risks. Right now, I'm working on a shingles vaccine candidate and I’m looking forward to seeing it through.

How did you get into regulatory affairs?

I'm a bioengineer, and I started in manufacturing. While I was working on manufacturing biologics, I interacted with the regulatory folks. And that's how I got interested in, and eventually transferred to, regulatory affairs. What I like about regulatory affairs is that it’s full of strategic inputs. I like to see the execution of strategy into quantifiable results, and that's what regulatory affairs provides.

How did you get involved with RAPS?

I found out about RAPS even before I got into regulatory affairs because I was looking for a legitimate regulatory affairs certification. So, when I decided to transition from manufacturing to regulatory, I searched for RAPS. It's a one-stop shop for all things regulatory, and a place for regulatory brains to meet, learn, and collaborate with each other. RAPS is a very important institution for all regulatory professionals.

What do you get out of your RAPS membership?

I appreciate the educational resources that RAPS provides and there is also a lot of strategic advice that you get from RAPS meetings, Convergences, and symposiums which is quite priceless for regulatory professionals.

Learn more about the benefits of RAPS membership.

Why did you like to attend RAPS Convergence?

We really want to be at a stage where we employ the latest developments that are happening--the latest guidance on the latest quality systems. Convergence provides a platform and the opportunity to speak to industry leaders and learn from them, and to embed that learning into my company. Plus, meeting like-minded regulatory professionals is beneficial, and Convergence is a one-stop shop for all things regulatory.