In this Q&A, Aman Khera, Global Head of Regulatory Strategy for Worldwide Clinical Trials, discusses her appointment to the board for The Organization of Professionals in Regulatory Affairs (TOPRA).
As the global pandemic has driven the pharmaceutical research industry to deliver results at an unprecedented pace, the role of regulatory affairs has become increasingly visible in the eyes of the industry, and of the world. What better time to shine a spotlight on Worldwide’s own Global Head of Regulatory Strategy, Aman Khera? In a recent Q&A, she spoke with Lindsey Johnson about her new role at TOPRA (The Organization of Professionals in Regulatory Affairs).
Lindsey Johnson: Today, I’m talking with Aman Khera, Global Head of Regulatory Strategy at Worldwide Clinical Trials, who has recently been appointed to a board position at TOPRA. Aman, do you mind telling us a little more about yourself and why you’re excited about this new role?
AK: Yes, absolutely. So, joining the board was something I’d been thinking about for quite a while. I have been a member of TOPRA, formerly called BIRA, for over 20 years. I also was a member of the Regulatory Rapporteur editorial panel for a period, as well, previously having been a member of the editorial panel of BIRA. I’ve been an active member in TOPRA in North America for over ten years, and currently am co-chair of the North American steering group, the leadership team of TOPRA North America. In addition to that, I’m also a member of the TOPRA diversity committee, where I provide my experiences and expertise as a diversity, inclusion, and belonging champion to help drive forward those initiatives for TOPRA members, with TOPRA now being a signatory to the Science Council’s diversity declaration.
So, really, after all this volunteering at TOPRA in different capacities, becoming a board member was the next step, I guess you could say, in my love affair with TOPRA. This is a real chance for a regulatory professional to actually influence the work of their professional body and to actually offer their time and talents to promoting TOPRA and the profession of regulatory affairs in general. I’ve always been about elevating the voice of regulatory affairs in our industry. And I’m really excited that I get a chance to help shape that strategy for TOPRA in these very interesting times. Members of the board will also help participate in the advisory council of TOPRA with leading figures in the regulatory affairs world, which is global, of course. So yes, I’m very excited.
LJ: Fabulous! What will your responsibilities entail in this position?
AK: I’m going to have the oversight of the activities of TOPRA in the North American network, and I’m going to help raise the profile and networking and educational provisions for this region, working alongside other members of the board. We collectively have the legal and financial responsibility for TOPRA, setting and monitoring its strategy, and, of course, the overall accountability for the organizational performance of TOPRA.
LJ: Wow, that’s awesome! Sounds like you’re going to be pretty busy. And, can you tell me a little bit more about TOPRA? What is the back story behind TOPRA, and why was it established?
AK: Absolutely. It’s a wonderful journey, the story, actually. TOPRA has been promoting regulatory excellence since 1978. The organization then was known as BIRA, the British Institute for Regulatory Affairs. Back in 1978, there were nine subscribers who actually signed on to the constitution, and they had a few objectives. Having a product go to market was poorly understood. No one really thought of regulatory affairs as an enabler of innovation. Well, that’s all changed now. TOPRA is now licensed by the Science Council in the UK to actually award the Chartered Scientist (CSci) accreditation. It’s been a fun journey for TOPRA, I have to say. It really has.
LJ: Wow, that’s really interesting. I love hearing the back story and how the role of TOPRA has evolved over the years. What have your experiences been with TOPRA so far?
AK: When I first started out in regulatory affairs many years ago, someone very respected in the drug development industry had said, “Congratulations Aman, you have joined an exciting profession, and there will never be enough regulatory professionals in the world because we just aren’t understood!” And that’s really stayed with me. I’ve found my involvement in TOPRA has actually helped so much with understanding what’s going on in the industry, the landscape, and touching base with other leaders and other regulatory professionals. People talk about the positives of networking. It’s beyond that; it’s like an extended family.
LJ: Wow. That is just fabulous. Do you see your role at TOPRA and your role at Worldwide blending in any way?
AK: Like I said, I’ve always volunteered at TOPRA and will continue to do so. And for me, as a regulatory professional, as I’ve developed in my career, volunteering at TOPRA, giving my time, my energy, my insights, my thoughts, it’s pretty much second nature to me, so I can’t imagine not doing something with TOPRA. And how will I balance everything? I think this owes to the fact that I’m so passionate about regulatory affairs and I’m so motivated to pay it forward, I guess you could say, lend my expertise and my insight and my experience to help continue shaping the profession of which I am a member. So, this is a natural evolution for me.
LJ: Talking about your career and how it’s evolved, what is an accomplishment that you’re most proud of?
AK: So, I think there’s no one set accomplishment or aspect in my career as such; it’s been evolving and growing more than anything else. But I’ve come to realize that helping other people in their profession, in their development journey, is something that I’m very passionate about. I’m humbled and honored to continue on my journey in regulatory affairs, lending my regulatory lens to clinical development of therapies and products in development phases. So, I think that’s what I’m probably proud of more than anything, continuing to help make a difference.
LJ: That’s neat, I really like that perspective. So, my next question is: As a regulatory professional, you’re always listening, watching, reading. So, what are you reading and watching right now that you think others might find enjoyable or interesting?
AK: I’m an avid reader and listener of thought leaders’ content, people that are shaping the industry, [those who are] thinking about how our clinical development is going to be changing and in what way is it going to be changing. So, there’s lots of activity on LinkedIn. There is lots of activity in virtual magazines, as well, lots of conversations happening in professional bodies and community chats.
There’s no one set resource or go-to person. And I think, more than anything, I’m learning to give more input or insights, to share my knowledge and experience and add to those conversations. I’m learning every single day. I think that’s the biggest thing, to continue to learn and be appreciative that change is constant and to keep a pulse point on that for sure.
LJ: I love that you’re not only reading and watching but also giving your own perspectives. That’s great. Okay, so my final question for you is: What’s your favorite thing to do on your day off, when you’re not being a rebel regulator or a TOPRA rep.
AK: I think, more than anything, it’s just to relax in these unprecedented times. We’ve been waiting for our puppy to come into our family, and he has arrived, so puppy life is consuming me at this moment in time.
LJ: That’s adorable! Well, this has been a pleasure learning more about you and TOPRA. Thank you so much for joining me and talking with me today.
AK: It’s been an absolute pleasure, Lindsey, thank you so much.
Get In Touch With Aman Khera
Interested in learning more about TOPRA or regulatory strategy? Reach out to Aman Khera now.