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The European pharmaceutical industry representative and strategist

Forming a view on complicated matters, involving legislation and policy, which influence many parts of pharmaceutical industry businesses, is an important challenge, says Sini Eskola.

Sini Eskola, regulatory affairs director at the European Federation of Pharmaceutical Industries and Associations (EFPIA)

Source: Courtesy of Sini Eskola

Sini Eskola is regulatory affairs director at the European Federation of Pharmaceutical Industries and Associations (EFPIA), based in Brussels, Belgium.

What is your background in pharmacy?

During my degree studies I worked in multiple community pharmacies and wholesalers. In 2005, when I graduated from the University of Helsinki with an MSc in pharmacy, I took up a position as executive director at the Finnish Pharmacists’ Society. In this representative role I became interested in a career in industry through the initiation of collaborative projects between pharmacists and industry. To develop my experience in this field, I took on the role of global regulatory submission manager in 2008, later global regulatory affairs project manager, at AstraZeneca, Sweden.

I ended up in EFPIA by being in the right place at the right time

I joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) in 2014 as director for regulatory affairs and am based in Brussels, Belgium. The EFPIA represents the pharmaceutical industry operating in Europe; our members include companies committed to researching and developing new medicines, as well as national pharmaceutical industry associations.

I was able to join the EFPIA by being in the right place at the right time; I was at the International Pharmaceutical Federation’s (FIP) conference a few years ago where I met a few members from EFPIA leadership. I later received a call from EFPIA to see if I’d be interested in a position in the scientific, regulatory and manufacturing team and the rest, as they say, is history!

My role involves both coordinating and leading on work related to scientific, regulatory and manufacturing aspects

What does a typical day in your current role look like and what are the main challenges?

My role involves both coordinating and leading on project work related to scientific, regulatory and manufacturing aspects. I represent the interests and views of EFPIA members when dealing with the European Medicines Agency, national medicines regulators and the European Commission. I also work a lot with other trade associations in similar fields, as well as with the representatives of non-governmental organisations.

I provide senior expertise and strategic advice in matters relating to legislation and policy (e.g. industry views on implementation of clinical trials regulation, environmental sustainability aspects, pharmacovigilance and technological advancements in regulatory data). I am also required to take notes from any meetings, in order to keep track of ongoing actions, answer questions from our members and participate and lead both internal and external meetings and events.

It can sometimes be challenging to form an industry view on highly complicated matters which influence many parts of the business, but also have a real-world impact. Each of the member companies may have different thoughts and strategies on how things should be approached, but the EFPIA needs to present a consensus view from industry.

Would you recommend a career in regulatory affairs to pharmacists?

Absolutely, it’s a great discipline for pharmacists to specialise in, as you really get an opportunity to utilise the skills and knowledge you have gained during your studies. Putting this knowledge into practice is one thing, but the role allows you to make the most of your knowledge. Understanding the different parts of what makes a medicine really helps too.

What skills and qualities would pharmacists contemplating a career in regulatory affairs need to possess?

As a pharmacist you are able to interact with other scientists and people from different disciplines because you have an understanding and speak the same language as they do. A successful career in regulatory affairs requires being able to see the bigger picture, adapt to an evolving environment but also an interest in continued learning to understand a broad range of topic areas in detail.

Pharmacists should not hesitate to gain experience in pharmaceutical industry

Good leadership and communication skills are vital for a career in regulatory affairs. Pharmacists should not hesitate to gain experience in pharmaceutical industry, it will provide them with a deep understanding of how drug development works and the ‘touching points’ with society (patients and their safety) as well as the role of the regulators.

What is the best piece of advice you have received during your career?

To stay honest and true and to be able to make decisions! In my role, it can be easy to promise a lot of things both to internal members but also externally. It is important to realise the limitations of what you can or cannot do on behalf of the association (and yourself). By remembering this you maintain credibility and command respect.

It is easy to get distracted by different pieces of information which point in different directions when trying to find the best way forward. It is important to get down to the facts, be equal and fair when seeking input from members or stakeholders and be able to make effective decisions when the time comes.

What do you hope to achieve in the future?

I would like to develop not only as a project manager, but also excel at being a manager of people. I like the idea of potentially undertaking a PhD, since I feel I’d like to allow myself time to dedicate to a topic that I’m passionate about. In my current role, I would like to work on improving the transparency of scientific data for the benefit of industry, regulators, physicians, and patients.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202499

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