Diversity Case Study: Ngoc-Tri Vo

Ngoc is a Regulatory Affairs Manager at Cell and Gene Therapy Catapult

How did you get into RA?

After a chemical engineering degree from Lyon (France) and a PhD in chemistry from Cambridge, I went to work in medicinal chemistry research in biotech and pharma. After seven years in R&D, I was looking for a career change. At the same time the pharma company I was working for decided to stop all chemistry on the site and offered a decent redundancy package. During the consultation period I have managed to get a bit of internship with the Eisai Regulatory group, where I have been given a crash course in Regulatory affairs and discovered that it was a far more interesting field than I initially thought. A few Months later, I got my first regulatory job in a CRO and have been working in regulatory affairs ever since.

What is your current role/area of work?

I am a Regulatory Affairs Manager at Cell and Gene Therapy Catapult, a non-for-profit government funder organisation that aims to develop the ATMP industry in the UK. My duty is to provide regulatory support to partners (academic and industry) who are looking to develop ATMPs. As part of the Cell and Gene Therapy Catapult Regulatory Group, I provide a consulting service and preparation of a range of documents: scientific advice, GMO submission, clinical trial submission, etc.

What challenges/opportunities did you face advancing up the career ladder?

There are two main challenges on the regulatory career ladder for someone with high qualification and substantial research experience.

The first and most difficult challenge is to get your first regulatory affairs experience. When I started to apply for regulatory jobs, my CV showed over-qualification and inexperience. This issue is made worse by the reliance of the industry on using recruiters, the majority of who are simply looking for keywords and counting years of “relevant experience”. Eventually, I found a CRO that was willing to take a chance and they offered me an assistant job. I was very grateful for the job, even if I had to accept a substantial pay cut as well as becoming the most junior member of my team. Fortunately, the benefit of such investment did not take long to materialise. My previous experience in research helped me communicate efficiently with our collaborators and understand their products. Another perk was my fluency in French, which allowed me to read regulatory intelligence directly from French national legal texts.

After two months I was made project lead, and within 10 months I hit the second challenge for career progression. After 10 months my CV looked greatly improved, as my regulatory experience was starting to compliment my previous qualifications. However, no company has a policy in place that allows fast career progression without causing serious upset in the workplace. Which leaves only one solution for fast career progression: “jumping jobs”. So I took a regulatory affairs manager position in a large charity, and have been progressing my career at a rapid pace ever since.

What does diversity mean to you as a RA professional?

I think regulatory affairs is a diverse field by nature, there is no standard way or degree that gets you into the profession, almost all the learning is on the job. In research, my colleagues almost all had the same qualifications/experience: we all had masters or PhDs in chemistry. In my current job I am the only one with a medicinal chemistry background, and that diversity offers amazing opportunity as a team for learning, development and problem solving.

What tips do you have for other TOPRA members about utilising diversity to improve business performance? How can focussing on diversity impact business outcomes?

It is obvious to me that diversity is a major advantage for any regulatory affairs group. One area I think companies could utilise as a source of diversity is to offer training/career change opportunities to their technical staff, to get them into regulatory affairs. Given the complexity of products, I would always recommend training regulatory professionals with strong technical backgrounds. Ideally, internal staff from the product development team could be trained on the job and, within 3-6 months, will be able to do all the required regulatory tasks adequately with the right mentoring.