Helen, Regulatory Affairs Consultant
I work as a freelance consultant in Regulatory Affairs for pharmaceutical companies. The work is very varied and depends on the client’s needs. Sometimes I work for a set period of time as part of their in-house regulatory team. Other times I will work in my office preparing licence applications for clients, or product licence variations, what ever may be required.
On an office day I will work through my emails and post. I try to do work for European clients in the morning and for US colleagues in the afternoon so that I can call people in the right timezone! I may need to contact the Medicines and Healthcare Regulatory Agency (MHRA) to discuss an ongoing application or begin to prepare a product licence application.
It can be lonely as a freelancer when the work is done remotely from the client although it still entails teamwork between yourself and the client. It is good to work in-house to top up on the interactions as it is easier to exchange information and pleasantries! Those in the pharmaceutical industry are a social bunch. I keep in contact with colleagues and there is a network for independent regulatory consultants.
I’ve have been working as a freelance consultant for over three years.
I’ve been working now in Regulatory Affairs for over 10 years. I started my career in regulatory consultancy working for a specialist contract research organisation working on a variety of products in varying stages of product development. From there I moved to Janssen-Cilag Ltd in the UK office for four years, working on a variety of products, including those for epilepsy and over-the-counter medications. After the birth of my son I wanted to work flexibly and chose to work freelance. I now work about three days a week and haven’t looked back!
I’m always making new connections. When freelancing it’s important to be able to go and say hello to people and ask questions as often companies have different ways of doing the same thing. Social media is a great way of maintaining connections when moving between clients.
Working on the development of a novel therapy for multiple sclerosis. Alas the clinical results meant that product development stopped before Phase 3, but it was so rewarding working on a therapy that, until that point, had the potential to help patients and my input could help get that product to the patients as swiftly as possible.
It’s always pleasing to see patient information leaflets that you have written being used by patients.
The job (regulatory affairs) looked interesting and it happened to be in the Pharmaceutical Industry.
I had worked as a scientist (doing my PhD) and liked science, but preferred to wear a suit rather than a lab coat. Regulatory Affairs allows me to use my science and logic at a desk job.
I have a BSc in Microbiology and Microbial Technology and a PhD in Biochemistry. I have 10 years’ regulatory experience having worked in roles at the Country, European an Global level.
I found my PhD useful in that it helped me to critique reports quickly and confidently, however, it is not essential. The Industry seems to want new starters with some experience, which can be a Catch 22. Some companies offer placements for Sandwich students – a great way of gaining experience.
What do you want to do? Regulatory Affairs is a truly transferable skill between countries, the skills are the same even if the legislation is different. It’s not unusual for consultants to go back to working for a company or one can continue freelancing, or set up their own consulting business.
Attention to detail and an ability to translate complex points into simple straightforward language. Logic and creativity. Diplomacy –convincing assessors that your point of view is the one to use, convincing clients that there are other options to consider. Self-motivation – if I don’t do the work I don’t get paid!
Go for it! Each company has a different culture and ways of working. The scope of opportunities is great and the variety and rewards are good too.
The outlook. Academia can be very focussed and in-depth, whereas in the pharmaceutical industry one is always aware of the bigger picture.