We interviewed Educo Life Sciences trainer Sophie Nageotte to get her views on a career in pharmaceutical regulatory affairs, specifically CMC. Sophie discusses her career experiences and provides some advice for those working in regulatory CMC. She also discusses why CMC regs is an exciting area to work in

Watch a snippet of the interview here:

 

Could you please summarise your career to date.

I have a chemical engineering background, so really scientific. I have worked in the Pharmaceutical industry for over 22 years now. I started at Galderma as a technical and regulatory affairs associate. Over 8 years I worked on the maintenance of the technical dossier of the products there. Whilst at Galderma, I worked on various projects such as the scale up for clinical batches and industrial scale up for post market.

Next, I went to Bayer Consumer Care working on the technical and regulatory side. I was CMC writer and CMC expert in a project team, dedicated to the transfer of manufacturing sites.

After Bayer I wanted to work for smaller companies. So, I left big pharma and went across the border to Geneva where I worked for two companies PregLem and Stragen. It was always on regulatory affairs and CMC, so contributing to registration of the products and also the post variations and post marketing maintenance of the products.

And after that I started to run my own freelance consultancy, which I have been doing for over 6 years now. I consult for clients working on regulatory and CMC projects such as writing variations, CTD Module 3, IMPDs and INDs. Also, I am a professional trainer providing courses on a range topics.

A good question to follow up with is why did you enter the Pharmaceutical industry? What led you to that career decision?

It is a funny story because it was completely by chance. When I left University, I was looking for a job located in the alps because I love the mountains. I came across this job ad, and they were looking for a chemical engineer who spoke English. I spent my last year of university in England at the University of Manchester so my English was good.  So, I applied for the job and was successful. This is how I entered the Pharmaceutical industry. I remember my first day of work, I did not know what a marketing authorisation was. I discovered everything on site and I just loved it so I stayed in the industry.

During your career, how have you seen the industry change, in particular regulatory affairs?

Well, it has changed a lot because when I started to work it was in 1998 which is a long time ago.  Regulatory affairs was quite different, especially for post marketing variations. Regulatory affairs for post market variations were almost non-existent. I remember having big fights with my plant manager because he did not understand why you should ask for permission from authorities to change anything in the production of the product.

Over time it has become much stricter and more comprehensive. A regulatory professional has had to adapt to this and understand more technical knowledge. They now need to fully understand what was being made, why we manufacture that way, why we control certain areas.

For those people who are maybe starting out in Pharmaceutical regulatory affairs, specifically CMC. What would be your advice? What would you say to a younger Sophie if you had the opportunity?

That she should not be afraid of having to learn all the time. Just because she is out of education does not mean she will stop learning, especially in the CMC side. With the scientific, technical side you always have to learn and learn and learn because you need to remain up-to-date with the latest technology which is state of the art.

For example, today, I am working on things that did not exist when I was at university and I am learning. I must learn and understand technology that did not exist when I was studying chemical engineering. So, you always keep learning.

Also, a soft skill which is important is being able to speak English. It is important and helpful to speak English in regulatory affairs. I am French and I work with a lot of French companies and there are a lot of people not speaking English. And it is a no go for this job. You cannot do regulatory CMC if you do not speak English.

 

“You always have to learn and learn and learn because you need to remain up-to-date”

 

What would you say is the best place for regulatory professionals to learn? Learning from colleagues? Reading? Training?

I think it is a bit of everything depending on what you need and what you can give timewise as it is time consuming. For me it is a bit of everything. For example, I am always reading and I still buy books that are made for University, academic level such as people doing a Masters (MSc) or undergraduate degree (BSc).

I attend training courses led by expert people. I have also taken night classes to get a new Diploma in biotechnology. I did this because I needed to understand biotech in my CMC Regulatory role as the biotech industry grew.

You mentioned the biotechnology side of things. I am guessing that has been big area that has changed a lot, especially in the CMC side of things. Is that an area that you found difficult to adapt to with a chemical background?

It was challenging. For me chemical molecules are simple. You have one small molecule, you know what it is and you have defined methods as part of a control process. And it is overall simple. But when it comes to biotechnology you have to be humbled. Because you know that you do not know everything and it is very complex. You must be very open minded, flexible and creative to identify solutions to problems. With biotech, there are problems you did not know existed until they arise.

What are the top skills or competencies someone in a Regulatory CMC role should be looking to improve?

As I said, always be able to learn. Keeping up to date is critical, so you need to be able to learn quickly. I think it is important that you like learning as well. Then I would say flexibility is important. Especially in regulatory CMC, when you are involved and writing the CTD dossier you are at the end of a long chain of actions of people doing things. Quite often there are situations where decisions are made at the last minute. Things are changed because we think the product will behave a certain way and then we conduct the studies, and we see that it is not the case. With new results we must do something else and explain something else. Sometimes you know what you will write in the dossier and have it all planned out. Suddenly, with new results, you must change everything and rewrite everything. It is important you are flexible and happy for these moments to occur – it is part of the job.

What do you think the pros and the cons are of working in CMC regulatory affairs?

A pro for me is definitely science, because I like science. Another pro is being able to see and have an input in a lot of areas across manufacturing/development. When you work in regulatory CMC you must work closely with production, the analytical development, the stability, the drug substance and the drug product. So, you see the whole manufacture of the medicine and you can also work on the development side, as well as the post market side. It is a job that allows you to see many areas of drug development and manufacture.

For the cons, it can be frustrating because you must change many things at the last minute. For example, you are told by someone you need something, but a month later that is no longer the case. This happens from the experts who have conducted the studies. Their information forms the basis of the dossier and when they change so too must the dossier.

This also happens with regulatory agencies, especially when the drug is sold globally. The regulations are not harmonised, and some countries have regulations that are evolving very fast. Quite often, what you knew a month ago is not true anymore and this impacts the dossier.

Where do you see the exciting or growing areas over the next say 5 to 10 years in Regulatory CMC?

Everything will be exciting in the CMC side because, as I said previously, things are changing. There is a new paradigm in regulatory affairs. It means we are changing from the ‘we do this because we’ve always done it this way’ too ‘we have to fully understand the product and know why we’re doing things a certain way’.

That also impacts the products that are already on the market. It is not exclusive to newly developed products. When you do variations for products already on the market, sometimes a ‘mini development’ is required to find lost knowledge. When the drug was approved in the 50s or the 60s the professionals knew what they were doing but that knowledge may be lost, and we must find it again. This will be particularly interesting for the small molecules. Of course, everyone is saying that biotechnology products are the future, and they are very challenging, very interesting. But I just want to say that it will not be exclusive. We will still need small molecules and they will always be needed. There is a big field of challenges with these small molecules in the future.