Regulatory Affairs: Past, Present, and Future

Aman Khera
Head of Americas, Regulatory Strategy and Agency Liaison

Aman spoke at a RAPS event in Vancouver on Thursday, April 26, broadcast real time to Victoria, to shine a light on what the future holds for the profession.

APRIL 23, 2018

The world according to regulatory affairs is changing more rapidly than it ever has; there has never been a more exciting time to be involved in the industry.

Our Aman Khera, Head of Americas, Regulatory Strategy and Agency Liaison, has more than 21 years of regulatory experience within the CRO industry. Here’s her take on the industry and its future:

What are some of the key duties regulatory affairs professionals tackle?

I must smile, I can’t tell you how much fun it is to explain what I do as a job – even more entertaining is watching my husband or sons explaining what I do to others!

The field of regulatory affairs is vast and limitless. In the life sciences sector, you can be a regulator in a bio pharmaceutical company, a regulatory agency, or within the consultancy arena. Regardless of where you work, the skillset of a regulator remains the same. Like other roles in the drug development arena, we thrive on making an impact to healthcare.

Understanding the science behind a potential treatment requires a sound scientific background; navigating the regulatory pathways for the development of that drug or device requires keeping up to date with the regulations that exist globally. Communication skills are essential.

Whether a regulator has regional or global expertise, regardless of whether working in CMC, regulatory strategy, clinical development, emerging markets expansion, or even involved in labeling and ad/promo or other post approval activities, the core skillsets required are much of the same across these specialized functions.

What was different in the regulatory landscape when you first started?

In this everchanging landscape of new regulations, laws, and new pathways for product development, I think the main thing that sticks out for me is that there is less use of paper. I remember preparing those enormous paper copies of submissions that were just mountains and mountains of folders; now of course submission management has evolved and electronic submissions through various gateways exist.  Publishing electronic submissions has become a highly specialized regulatory function in itself.

What’s a big mistake you’ve seen in the field?

Regulatory Affairs is not just at one point or chosen points in the development of a potential drug candidate or medical device. If there is one thing that I say often and never enough is that regulatory must have a seat at the development table from day one and they need that seat open for as long as the drug is available on market.

No matter how much or little assistance a client company may need, I invite them to engage in a discussion with us to see exactly how essential regulatory affairs is and how we can help shorten the time to market and position a product for commercial success by accurately navigating through the complexities of development, registration, and beyond.

What led you to work in this field?

During my degree in Medical Biochemistry whilst undertaking industrial placements, I came to the conclusion that I did not want to work in a lab environment; my final placement was in a compliance role and this reaffirmed my wish to use the scientific skills I gained outside the lab.

I had come across a pamphlet at the university career’s office about careers in Regulatory Affairs. The appeal of global laws, regulations with science, medicine, and business, was instant. I was warned that most people usually join Regulatory Affairs having become established in other fields first and was advised to look for something different as it was a difficult field to break into. That did not deter me, and I sought to look at companies that would consider me.

Within a couple of months after graduation, I secured my first position in Regulatory Affairs in a global CRO and I haven’t looked back since. I frequently give talks to students at schools and universities about careers in the drug development field and remind them to never be deterred and never give up your dreams.

Tell us about your professional journey.

My job has not remained the same through the years as PRA is constantly innovating and evolving. My role is always changing; the innovation allows me to develop and make real change impacting patients’ lives every single day.

Through the years, I’ve worked with countless client companies; some very large, some midsize, some virtual biotech companies across the world, in a multitude of therapeutic indications, their products at various stages requiring regulatory expertise.

The work has varied, whether it be determining the best regulatory strategy for developing a drug or device in the early phases of research to ensuring a product in development is on the right path for regulatory approval or negotiating with regulatory agencies on behalf of a client company.

My journey hasn’t just stopped there. I’ve been involved in many initiatives. For example, I’ve worked on countless business development opportunities and developed the Regulatory Intelligence function here at PRA. Recently I developed a rewards and recognition program unique to a partnership platform You name it, I’ve probably done it sometime in my career!

Through the years, as the company has grown I’ve been able to mentor and train regulatory professionals who are on their own journeys. That has really fueled my interest in the people aspect of business, especially in a service organization. After all, building, engaging, and retaining regulatory teams directly translates to successful product development and maintenance.

Being a woman of ethnic minority, of visible Sikh faith, my lens with which I view things is unique to me and it is very important to me to be in a diverse and inclusive environment that celebrates and respects when I bring my whole self to work. In my spare time – you can call it a side gig – I’ve become a Diversity and Inclusion champion in industry. Medicines and treatments know no barriers, and people involved in drug development should not feel barriers either. Another interest of mine is to look at the several generations at the virtual water cooler at work, because to engage all different generations requires inclusive strategies.

Where do you see it going in the future?

That’s a loaded question! There has never been a more exciting time to be within regulatory affairs. I could talk for hours on the future of regulatory affairs, with new regulations and innovative technology taking center stage. I also think industry and regulatory agencies are collaborating more closely on these types of initiatives to personalize medicine and collect patient input on potential treatments. Regulators are at the forefront of these collaborations.

For example, I know there is a lot of talk on machine learning and Artificial Intelligence (AI). AI is not going to negate the need for people in this field but rather the field is going to adapt and evolve; it’s happening right now. More and more the personal approach is going to matter. The human aspect cannot be ignored. Personal soft skills for a regulator are going to be just as important as the technology that that will help revolutionize drug development.

Aman has been with PRA for over 16 years, originally based in London UK she now resides in Vancouver, Canada. She is an active volunteer in regulatory associations; serving as Chair of the North American Leadership team of TOPRA as well as a member of the TOPRA Diversity Committee in addition to the RAPS Vancouver Chapter. Last year she was shortlisted for an industry wide Regulatory Excellence award under the Inspiration category.

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