Regulatory Affairs Career Advice

An interview with Educo Life Sciences Trainer Andrew Willis

We interviewed Educo Life Sciences trainer Andrew Willis to get his views on a career in regulatory affairs. We discuss top tips to those looking to start out in regulatory affairs but also provide some great advice for people looking to transition into new areas such as ATMPs (cell and gene therapies).

Watch the full interview here:


Why did you enter the pharma industry? And Regulatory affairs?

I started a long time ago, 37 years ago now in the pharmaceutical industry, and I took a job within the quality assurance laboratories with no real knowledge and no real expectations. However, once I got into the industry and got into the career, I really enjoyed it so I furthered my education with specific degrees in biochemistry and chemistry and developed my analytical skills. I went on to become an analytical development chemist and then entered research and technical services and progressed through normal pharmaceutical development. My core background was as a chemist and as a pharmaceutical development person: formulator, trouble-shooter, those sorts of skill sets, very data orientated.

By chance things move and industries change, and companies change as well. I had an opportunity to transition into a role which was supporting the regulatory CMC development and I ended up writing the quality element of CTD dossiers (module 3). I wrote the module threes for the company I was working for, which was Merck at the time. I developed the skill sets and started having the wider skills for regulatory strategy generated from discussions within that team. I quickly fell in love with regulatory affairs, fell in love with regulatory clinical, nonclinical and CMC so the whole strategic perspective.

In the role, I had lots of interactions with business teams, with commercial teams, and that made me very business aware and strategic. Over time I transitioned from a ‘doing’ regulatory affairs person to regulatory strategist.

I moved around in various positions before gaining exposure to biologics, monoclonal antibodies and ultimately exposure to things like cell therapies and gene therapies as well. That was a great career, I loved it, I loved everything I did.

After that I became a consultant for around 12 years and then I re-entered the pharma industry as a senior vice president for quality regulatory and CMC at chief tech officer level. Being part of the C-Suite I was responsible for raising finance, monies for a biotech company working in cancer vaccines. Moving forward I’m also working in cell therapy and neutrophils for advanced therapies which are intended to treat oncology and hopefully will be extremely successful.


What is the typical route into regulatory affairs?

First, I do think courses like the introductory regulatory affairs course are good courses to do, the optimum time to do them is probably 6 to 12 months after you’ve been in a job, but they give you a broad understanding of the wider picture.

Regulatory affairs is such a broad spectrum of activities and you can specialise within regulatory affairs such as CMC, clinical, project management. there is also the opportunity within small companies to see everything that you could ever wish for and it’s one of the disciplines which crosses all boundaries and all areas.

My analogy of regulatory affairs people is that they are the cement between the bricks in a building and they join everything together and when you’re successful in regulatory affairs you’ve been able to link everything successfully and you built a perfect house for the story, for the product, going forward.

Entry into that usually comes from areas like clinical research or CMC, analytical, formulators. Either route is possible, and many people do a few years in the laboratory or as a junior formulator or as a junior clinical research scientist, and then enter regulatory affairs in immediate roles.

The skills required for regulatory affairs include: very good data awareness, very good root cause analysis skills, you can detect things, you’re very good at linkage, you’re very good at joining concepts together and processes. The work you do in regulatory affairs is all about presenting knowledge across effectively, and those skill set are the ones that distinguish the top regulatory people from routine regulatory affairs.


How has the industry changed during your career?

The industry has changed dramatically, not just in regulatory affairs but how we think about drugs, our concepts, the way we think about developing and there’s lots of things which have changed with time.
Traditional drugs that we have today were designed for men. Nowadays we think about all sexes, all people, we think about the full demographics and we’re inclusive. So, we think about women in terms of how we design clinical trials, we think about children. That inclusiveness has changed significantly.

Also, there are lots of better incentive systems to allow orphan drugs to come to market, to enable exposure of orphan drugs to everybody. One would say there’s 100 million people added to the middle class every year and that’s a World Health Organisation statement. The trouble with that statement is it really refers to people who can afford medicines, and this is the exposure and drive of many of the pharmaceutical companies.

Working with organisations, with the World Health Organisation, means pharmaceutical companies are embracing many more disease areas. That recent exposure to new mRNA technology for COVID was revolutionary on how fast we can develop and manufacture good products, like the BioNTech and the Moderna vaccine systems. But mRNA, sRNA, cell therapy, CAR T-cell therapies, are changing the way we think about doing trials, they’re changing the concepts on how we can treat patients.
The revolution in things such as monoclonal antibodies that fully humanised systems, we’ve advanced them to bi-specific antibodies, we’ve advanced them to targeting molecules, we’re given peptides which change your immune systems. So, our scientific understanding is changing completely and therefore, the word regulatory affairs has changed very often as well, I like to say its regulatory science.

You have moved from small molecules to biotech and now ATMPs – What would be your advice to people doing the same?
It is very hard to give tips, many of the things that we’ve learned from biologics (monoclonal antibody developments), we now retrospectively apply them back into small molecules. These include concepts of quality by design and manufacturing linkages between the materials, the process and the product. The actual linkages to things which impact safety and efficacy have always been important to us, but never to the level that we see today.

The understanding that you have to have when you move to ATMP is the importance of the fundamentals; the importance of high quality, the importance of control strategy, the importance of things such as control strategy, the important of materials and concepts. People get scared of very large words, the meanings the definitions. I don’t think you should ever be scared of those; those are things you can always learn, you can pick them up. You can understand what a stem cell is, you can understand what stemness is, you can understand what viral vectors are.

What you must always remember are those fundamental linkages of what you’re trying to strive for. For cell and gene therapy, it is good boundaries, good set systems, good quality systems, good material controls from as early as possible.

When we look at small molecules, it is very rare that anything will fail due to a CMC issue. The CTD dossier is weighted approximately about 15% CMC and the rest is nonclinical, around 25% and 60% clinical so the weighting of emphasis is all on the clinical data. When we move up to larger molecules like monoclonal antibodies the weighting changes somewhat so you would argue that you’re up to around 25% CMC, 25% non-chemical and 50% on the clinical. The big jump is when you get to ATMPs and cell and gene therapies where basically the weighting becomes one third, one third, one third because the importance of the chemistry and manufacture and linkage to immunogenicity is critical. The suitability in the disease state, the diseased human, is critical to understand. The mechanism of action, the mechanistic understanding, the bio distribution, is critical to understand, and so they are all equal. Because of this it is important to put the right teams together, the right emphasis, starting the right process together at the right time, that’s a different mindset and you have to be able to jump that mindset.


What would be your advice to those starting out or early in their regulatory career or wanting to move into regulatory affairs?

I would say start at the bottom in regulatory affairs, and you work up, but the thing to do is keep an open mind. Regulatory affairs is not about pen pushing, filling forms. It is important to get accuracy and it’s a really fundamental brilliant skill set to have and skill sets that we must promote. It’s not about knowing every single guidance, that’s a technical impossibility. Regulatory affairs is about the logical thinking about knowing why you should do things, knowing what the expectation is, knowing how to drive the complete story. So don’t forget your project management skills, don’t forget your connectivity, don’t forget your listening skills, be commercially aware, be business aware, be financially aware as well as scientific. Get into the science, talk to the formulators, to chemists, talk to the medics. Don’t talk to other regulatory people, talk to the actual people, the scientists as well, and that will expand your knowledge, that will expand your capabilities.

In but don’t leave it at those scientists, go into the financial areas, go to the business people and talk about the concepts of what they perceive, how they perceive regulatory affairs. If you can cross that barrier between science and commerciality then you’re the brilliant conduit and that’s regulatory science, that’s regulatory affairs. The people who shine in regulatory affairs are the people who have that communication skill set, because many people in commercial and finance just see you as a barrier, they see you as an obstacle to getting the product to the market. Great regulatory affairs people facilitate great products getting to the market easier and quicker.


What are the exciting/growing areas in 5 to 10 years. What can professionals do to help prepare and upskill?

I think there’s huge numbers of areas of growth and excitement, there’s areas of growth obviously in ATMPs. To name a few: antisense, CAR-T cells, the allogenic Holy Grail of pluripotent stem cells and the combination of many gene therapies both viral vector, non-viral vector transduction of information.

But there are other exciting areas, even in ATMPs there are areas such as extracellular vesicles, the exosome treatments which are being explored today by companies. But then there is new stuff, combination treatment, the connection between products and devices and the ability to implement and work together, so many products will become combination products. I have done things from intracerebral injections to implants to make sure products are working effectively at the right place at the right time with the right regulations. I think there will be a huge expansion in how we combine the quality standards for devices and drugs. How we combine the quality expectations and the GMP and how we present information for combined drug/device combinations will be important, and then finally there is how the wider world is operating as well.

Connected health is something that you’ll see more and more coming through, so we’ll start monitoring patients with diabetes constantly and we will be intervening because of things such as electronic monitoring apps. These apps will tell us our levels of insulin, and tell us when to change our drugs and tell us when to have a shot of insulin or something of that nature, or tell us when you might have a heart attack, or tell us when you are getting ill, and the diagnostic and combination of understanding your body coming back to us is going to be huge.

So connected health that’s one, combination product is two, but also the excitement of ATMPs, the whole plethora of such technology they’ll treat such as cancer.


Andrew teaches on the following courses:

Overcoming Regulatory and Quality Concerns for Cell and Gene Therapies

Completing the Quality/CMC Module of the CTD


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