Our latest career profile is Vicente Tur, Director of Regulatory Affairs at Asphalion, a scientific and regulatory consultancy with offices in Spain, Germany, the Netherlands and the United Kingdom
Regulatory affairs is one of many non-research professions tightly linked with pharma and biotech industries. Roles in this area may be in-house, in the pharma industry or at consulting firms; their focus is on keeping up-to-date with industry regulations (at the national and international level), working with scientists to ensure that R&D is completed and documented in a way that will enable a product to be authorised at the end of the development process – including that the active substance and finished product are manufactured with the controls required by the Regulatory Authorities. It also involves preparing and submitting administrative documentation for the regulatory authorities.
In the interview, which can be found below, Vicente tells us more about this profession, how he moved into this area, and what he is looking for when hiring for his team.
If you’d like to learn more about this area, resources include:
- Regulatory affairs officer – PROSPECTS Job profile
- From Research to Regulatory Affairs: Long Journey to a Complete Life Cycle – Science Careers
- Working in regulatory affairs: careers and trends – Northeastern University
- Finding job satisfaction in regulatory affairs – Nature Jobs
- Professional bodies for regulatory affairs professionals: TOPRA – RAPS
For those not familiar with the area, could you briefly summarise what regulatory affairs is?
Our work is ensuring our customers comply with all the regulations that are there, to ensure that they understand the requirements to be able to obtain the authorisation to commercialize a medicinal product in the different regulatory areas; and also the regulatory requirements of medicinal products once they are on the market. In my case, I am not working for a specific pharmaceutical company, but we are a consultancy, so in the end, we have many different types of products, projects and many different customers. We have teams specialized on medical writing, which is closer to writing a paper – where you are writing scientific documentation that provides the regulatory authority information on the safety and efficacy profile, and manufacturing processes for the molecule the company would like to launch as a medicine. In the regulatory affairs sector, we put together all these documents from a variety of sources. Regulatory affairs is a combination of this administrative work and also more strategic work – we also really help our customers to understand the requirements from the regulatory authorities.
This information nowadays needs to be submitted to the authorities in electronic format – at the end, you have a structure which is called the electronic common technical document (eCTD). You need to organise your documentation in specific ways. You even have specifications to follow and a technical validation from the application that you submit to the different authorities. And you have a lot of things apart than the scientific and technical content of the dossier. I took advantage of my joint degree – I am a biochemist, but I was in the structural and computational biology programme at EMBL and was able to link computers to regulatory affairs: the speciality of my team is eSubmissions. Not everyone has the expertise to understand both sides: computational work and regulatory affairs.
What does your role involve?
It involves everything! Asphalion is an SME (small-medium enterprise), but we’re reaching 100 people! I try to take care of everything: from training new team members, helping customers do a proper planning of their upcoming submission, meetings for strategic advice on timelines they have on mind, really helping them to understand if what they have in mind is realistic or not and making them aware of the potential hurdles that they will be having to face, so they can plan them in advance. But also internally, I’m involved in many things from invoicing and internal planning, to developing new services in my team, maintaining ISO9001 quality system, meeting with customers and providers, internal meetings for strategic plans for the company for the next year, sometimes even speaking at some event or training course. Maybe in a big pharma company, the same role with the same name would be more focused – but this is what I like about being in a consultancy company. Doing a little of everything keeps the role challenging, and you’re doing something new every day: anything that is needed either internally or by customers, we do it or help them to do it. If I go deeper on the subsector I am in: eSubmissions, we centralize everything that is “electronic” and “telematics”, and nowadays the sector is going through a huge change, from the recently implemented eCTD format for paperless submissions to the regulatory authorities to the upcoming implementation of the new standard ISO IDMP to standardize the data related to medicinal products, authorities portals and databases, advanced software implementation in industry, data migration… every year there are new requirements and challenges.
How did you end up in this role?
I did a PhD at EMBL Heidelberg. By the time I was completing my thesis my supervisor, Luis Serrano, was moving to Barcelona to the CRG in Barcelona. I moved with him to finish some projects as a postdoc. Then I reached the point everyone gets to in science sooner or later, where you have to decide what to do next. To stay in science, the next step would be to do a second postdoc – in those days it was usual to do that in the United States. But I was really happy in Barcelona and wanted to stay there. So I moved to a local biotech, Oryzon Genomics. There I was working as a platform leader for high-throughput screening of potential molecules. That was nice – it wasn’t so close to academic research, but it was still wet-lab and drug discovery. It was the beginning of the pipeline of the sector I’m currently working with. It was a robotics platform – we adapt ELISA and other assays normally done in a wet lab for robots. The robots were doing these automatically. A person performing the assay can – for example – see if there is still a drop on the pipette and press again to eject it – and we had to work out how to factor these things in.
That was an intermediate for me – I left academia without leaving the wet lab. Then I moved to regulatory affairs. I knew that there was this company in Barcelona, Asphalion, which at the time was quite small. I thought this might be one way to get deeper into the pharmaceutical sector and away from the wet lab. They gave me an opportunity although I was totally inexperienced in regulatory affairs, and I got a position as a technical officer.
And then you moved up?
Yes, basically I started as an officer and was promoted to manager then associated director and now director.
From your experience, would you say that it is typical for people going into regulatory affairs roles to have other industry experience first, or have you also come across people who come directly from a postdoc or PhD?
I think I’ve seen all possibilities. It also depends on the specific subsector. For example, medical writing – which is basically, if you allow me a simple comparison, like writing a big scientific paper – is more similar to the work in academia, so it’s easier for scientists to do a transition into this area. For regulatory affairs, you need to read a lot of EC regulations, technical guidance, so there is very little in common with the jobs I was doing previously. There are lots of different ways to go into industry.
What have you found most challenging about working in regulatory affairs?
The answer is crystal clear for me – especially working in a consultancy: the answer is timelines. When you are doing a PhD or postdoc your timeline is years – you have funding, for example, from Horizon 2020 and you have three to four years to do your project. Even writing a paper is a timeline of months. In consultancy for the pharmaceutical industry the speed is very different – we have projects for months or weeks – sometimes even days, and we have many different customers with different needs.
Do those timelines impact your work-life balance?
Industry is very absorbing, but it’s the same in academia. At least in my case, I can say my employer takes really care of us. There will be times when you have a work peak, and you need to solve the needs of your client almost immediately. But if you are working a lot on a project, this is compensated – for example, you might be able to take additional time off. Of course, this depends on the company – but many already know that the happier you are the happier your customer will be. So it is tough, but it is compensated, at the end the answer is flexibility.
What is the most enjoyable about working in this area?
One of the things I like the most is that it is never boring. I would say that this applies not only to the field of regulatory affairs but also as it is a consultancy. At the end, you will always have clients with new needs, there are always new regulations. You need to be adaptive. On one side this could be seen as a challenging, but it also what make the work exciting and so that you don’t get bored doing the same thing after a couple of years.
What skills and character traits do you think were needed for you, and others, to be successful in regulatory affairs roles?
When I was doing the interview for this position, I really had to sell myself. You don’t have experience, but you already have the skills of working in an international environment, which is really a key plus. You have the ability to understand and learn new things – the regulation is public and available, you’ll need the experience to get more familiar but it’s only a matter of time. The skill of knowing where to find information is also needed for a PhD. Also, the skills of project management you also get in academia – visualise a project, draft how to start the project, evaluate the risks and opportunities of the field. With the exception of the technical knowledge, which you will learn with time, you really have the skills from a PhD or postdoc. Not everyone is aware of these non-technical skills they have. Communication is another one – being able to communicate to people and adapt this to who you are to talking to.
Is there anything else you look for in an application?
Of course, experience in the sector is interesting – but people can start in a junior position without this. What I am looking for is experience in an international environment – this is important. Another thing I really like is people who are proactive – who proactively read guidance and are eager to learn new things and adapt quickly. Every year in this sector there are new guidances, regulations and challenges. So even if you know everything, in some years your knowledge could be obsolete. You need continuous learning. Having a PhD could even be a plus – it shows that you are not scared of learning and adapting and reinventing yourself every year. In this specific case, as we work with electronic formats and specifications, liking computers is also a plus.
In what ways is the work you are doing similar to the work you did in academia and in what ways different?
From a technical point of view, my work has nothing to do with what I did in academia. But from a strategic point of view it’s not that different: at the end of the day, everything is about projects and timelines, about being able to write a realistic project plan and allocate resources properly. It’s complicated to answer this question – but I believe I wouldn’t have been here if I didn’t have a PhD and postdoc beforehand..
The office you work in is in Spain, but Asphalion is international. Is the working language Spanish or English?
It’s English. This is one thing I love about my team. We have people from everywhere – of course, we have Spanish people in the team, but my team manager is Czech and we have officers who are British and Italian. It’s a really international environment and we have customers all over the globe.
Is there anything else you think important to mention, that we haven’t covered?
I’ve been quite active in a number of forums providing advice to PhDs and postdocs, like ENABLE or PRBB career chats. What I see is they sometimes get really discouraged, because everything gets reduced to a matter of experience in Industry – so they might hear “you don’t have experience and you’re already 30-something or 40-something”, and opportunities also don’t come up that often. But you will always find someone who will give you a chance to show what you can do. The only thing they lack is the technical knowledge, which they can acquire in a couple of years. I’d advise not to get frustrated if you have a few HR interviews and are discarded. It happens, you just need to be persistent – and prove that you have the interest in this, and that you can learn / adapt quickly. This is something a PhD gives you: you have a plan, but you have to adapt as your first experiment generally doesn’t work and you need a different approach. Even if you need to start in a junior position, that will be a transition while you learn the new sector and then you’ll be able to go further.
You mentioned earlier that not everyone is aware of these non-technical skills they have. In the EMBL Fellows’ Career Service, we also see that once those skills are recognised, it can take a bit of practice to really communicate those skills well. Is that also your experience?
Exactly, it’s about communicating these skills properly, both in terms of CV and personal interview. It probably takes 2-3 interview until you reach a point where you understand how you should be communicating. Luckily there are more and more resources available for this nowadays.
You can find Vicente on LinkedIN here.
EMBL fellows and staff who would like to contact Vicente should contact the EMBL Fellows’ Career Service, who can put you in touch with him. EMBL personel can also contact other alumni working in similar roles via the EMBL alumni directory. This can be used to seek career advice / informal mentoring. Please see our article on informational interviews for ideas on how to make the most of such opportunities.