In this article, we shine the spotlight on Jill Challis, Principal Consultant at NDA, and learn how her curiosity led her into the pharmaceutical industry & Regulatory Affairs.
The many sides of regulatory affairs
With over 25 years of experience, Jill Challis, Principal Consultant at NDA, has extensive experience in European Regulatory Affairs covering all phases of product development and many therapeutic areas.
Jill started her career in regulatory affairs at the Ministry of Agriculture in the UK, where she was involved in reviewing safety and environmental data, and contributing to the Regulations governing the safety of pesticides. Jill was passionate about contributing to formulating regulations and policies that helped keep people safe.
"We removed a lot of old pesticides that were dangerous to farmers and wildlife; we knew that we were making a big difference to people’s lives. I enjoyed reviewing the data and presenting recommendations to Committees — that was actually my first taste of regulatory affairs. I love regulatory affairs because it has a bit of everything, and you can clearly see how you are contributing to the whole product development journey, and its impact on the world around us".
Jill enjoyed working in a government agency, but also wanted to broaden her horizons, so she started searching for other opportunities in consultancy and pharmaceutical regulatory affairs. She got a job as a consultant, managing a broad range of projects from non-clinical to clinical pharmaceutical aspects. Part of her job involved travelling to work with clients from across the globe, and she enjoyed it.
After working in consulting for a while, Jill wanted to have a taste of working in industry. Her curiosity led her into the pharmaceutical industry, where she worked for large and small biotech companies in various roles as Regulatory Manager and Senior Regulatory Affairs Advisor.
Fortune favours the prepared mind
When Jill decided to start a family, she was keen on maintaining a balance between work and family.
"We had NDA consultants on site at the Pharma company I worked for and I discussed a part-time role with the VP of Business Strategy at NDA at the time, and that was how I got back into consulting, and I have been with NDA now for about sixteen years".
"NDA offered me the flexibility I was looking for, and on top of that, amazing colleagues to work with, because of their team spirit, collaboration and expertise and the projects are really interesting too".
Jill provides strategic advice and project management for EU Regulatory submissions and supports her clients with products, some of which are for rare conditions in early development and require efficient regulatory pathways, through to clients with Centralised MAAs; Jill has specialist expertise in developing EU Paediatric Investigation Plan (PIP) and US Paediatric Study Plan (PSP) applications.
When asked about her role at NDA, she said:
"At NDA, our priority is to make a difference in the lives of people across the world by helping our clients to produce effective and safe medicines, and that is what I love to do. My day typically involves meeting with clients, listening to their unique needs, and ensuring we have the right NDA team in place to support them with the right expertise. I am passionate about building relationships and effective teams. That is how I can support the variety of clients we have at NDA — clients with different types of products at different stages of development".
Getting on the regulatory road
"My experience working in the pharmaceutical industry helps me understand how pharma companies work, such that when I’m engaging with clients, I can understand what they want and how I can help them. As a consultant, I have learnt how to plan because every day presents a different challenge, and by working on different projects, you need to be flexible and adaptable".
In case you are wondering how to grow a career in regulatory affairs or if this field of science is for you, Jill has this to say based on her experience:
"Being a consultant means providing solutions to clients by applying your skills and experience to their situation. Maybe you can start out working for a consultancy or small pharma, where you can gain experience in different aspects of regulatory affairs; you can specialise if you find a particular topic of interest e.g. rare diseases, paediatric conditions, advanced therapies, and help both your clients and colleagues to navigate complex regulatory situations. Most importantly, is for consultants to stay updated with what is happening in the Pharma regulatory world because of the constant changes that are happening, which impact getting important medicines to people and its our role to facilitate this journey".
