novo nordisk regulatory affairs– entering the future of drug development

Racing into an exciting future – an interview with Peter Bonne Eriksen, senior vice president of Novo Nordisk Regulatory Affairs

437 people in Regulatory in 70 countries all over the world

A company that sees you for who you are– an interview with Jane Møll Pedersen, senior regulatory affairs project manager

Exciting challenges Great colleagues International relations

An interview with Peter Bonne Eriksen, senior vice president of Novo Nordisk Regulatory Affairs

Why is Regulatory Affairs in Novo Nordisk the place to be?At Regulatory Affairs we play a key role in making current and future life-saving products from Novo Nordisk available to millions of patients all over the world. I cannot think of a more motivating challenge.

We are dedicated to developing and produc-ing drugs that save and change lives. Knowing that we are responsible for the regulatory side of our existing portfolio, as well as a pipeline of drugs that really make a difference to the patients, gives me a real sense of urgency.

What is special about working in Regulatory Affairs right now?The fact that the global regulatory environ-ment continues to experience significant change makes it a really exciting and chal-lenging area to work in. The regulatory con-tribution to drug development has become increasingly important, which is also why Regulatory Affairs is increasingly becoming an important strategic partner in the whole drug development process.

The somewhat dusty image associated with the regulatory discipline a few years ago has now been replaced by a new kind of regula-tory professionalism. The field of Regulatory Affairs has become less predictable with the explosion of drug regulations and the accel-eration of the science and technology behind biologics development.

Who is the “new” regulatory professional?Navigating in the global regulatory environ-ment has become increasingly complex and consequently a new kind of regulatory professionalism has emerged at Novo Nordisk Regulatory Affairs. Of course, we still have to stay on top of regulatory guidelines. But in addition to this classic regulatory requirement, we must also master the art of combining our deep regulatory knowledge with an understanding of the challenges of the clini-cal processes at Novo Nordisk and strategic marketing objectives.

The core of this “new” regulatory profession-alism is the ability to provide strong proactive strategic input for our business partners. We proactively provide regulatory scenarios and take a leading role in pushing forward, from the earliest idea phases in R&D to the launch and post-approvals of Novo Nordisk products.

Very often we navigate in a regulatory land-scape where there are no specific guidelines. In such cases, tight and productive interac-

tions with the authorities together with a solid overview of existing practice in the field are key to creating ambitious and robust regula-tory strategies. This places high demands on our ability to translate authority state-ments and existing approvals into a navigable regulatory landscape and to communicate the regulatory options to our business partners.

What is the ambition of Novo Nordisk Regula-tory Affairs?Novo Nordisk is a global market leader in diabetes care. Novo Nordisk also has a leading position within such areas as haemostasis management, growth hormone therapy and hormone replacement therapy. In addition, Novo Nordisk has an exciting and extremely promising pipeline of new products.

In other words, working in Novo Nordisk Regulatory Affairs means you are part of a winning team. Novo Nordisk is a global mar-ket leader and this also applies to Regulatory Affairs. We want to be the best Regulatory Affairs unit in the world, and we want world-class employees to race with us towards a very exciting regulatory future.

Regulatory Affairs in Novo Nordisk racing towards an exciting future

“ At Regulatory Affairs we play a key role in making current and future lifesaving products from Novo Nordisk available to millions of patients all over the world. I cannot think of a more motivating challenge. ”

“ The fact that the global regulatory environment continues to experience significant change makes it a really exciting and challenging area to work in.”

“ We want to be the best Regulatory Affairs unit in the world, and we want world-class employees to race with us towards a very exciting regulatory future.”

Right: Peter Bonne Eriksen pushing the limits during a Regulatory Affairs

teambuilding event in 2008.

“ The core of the regulatory professionalism is the ability to provide strong proactive strategic input for our business partners.”

Peter Bonne Eriksen,senior vice president of Novo Nordisk Regulatory Affairs

52% of us laugh five times or more

during a day in Regulatory Affairs

Novo Nordisk Regulatory Affairs has simultaneously

submitted new drug applications in the US,

EU and Japan

We are 437 people working in Novo Nordisk Regulatory Affairs in 70 countries all over the world

17% of us ride our bikes to work

29% of us have shared an address with another Novo Nordisk employee

We have studied 2023 years at university

Credit: NASA Goddard Space Flight Center. Image by Reto Stöckli.

71% of us think Novo Nordisk Regulatory

Affairs is the best place we have ever worked

We have an average of 7.5 years of regulatory

expertise

Individually, we go on 7 days of training

every year

We had 5645 travel days in 2008

58% of us have performed on stage

34 of us blog

51% of us practice arts

51% of us make more money than

our partners

Novo Nordisk Regulatory Affairs

master eCTD publishing adapted for local

requirements

55% of us speak three or more languages

I joined Novo Nordisk in 1996 as a regulatory professional. Now, I am a senior regulatory affairs project manager heading up the SIBA project within Regulatory Affairs. My responsibility is people management, combined with a strong focus on regulatory issues around the project.

I think Novo Nordisk as a company aims higher; it takes a more holistic view. We have the Triple Bottom Line concept ensuring that we act socially responsible, financially viable and environmentally sound. It is not just about getting the job done; it is also about the way you get the job done – the way you interact with your colleagues and stakeholders. The Novo Nordisk set of values defines how we work together and achieve our targets. That high standard means a lot to me.

I also believe Novo Nordisk has this great ability to see people for who they are – both patients and employees. Of course, we need to hire the right people from the start, but when we have done that the focus moves to finding out who the person really is and where we want to go with him or her.

We are certainly thinking about long-term perspectives when hiring people. We are ready to do this extra bit that is needed for a person to do well here. It is not necessarily so, that a new person needs to be up and running on day one. It is an investment in the right qualifications, in the right person and the right capacity. I certainly feel we are open to hiring people that might not fit into the job immediately, but who we feel have the potential to grow within the company. When somebody like that comes along, we are ready to invest in that person.

There are two perspectives to a life-changing career; it is the change for the patient, and as long as you are working for Novo Nordisk you are contributing to a better life for people with diabetes, haemophilia and growth disorders. I think that Novo Nordisk gives you a different perspective on your life. You feel that you are contributing to something that has a higher goal.

Jane Møll Pedersen, senior regulatory affairs project manager

“ It is not just about getting the job done; it is about the way you get the job done.”

Jane Møll Pedersen, senior regulatory affairs project manager

Exciting challengesGreat colleaguesInternational relationsAccording to the employees, these are the top 3 reasons to work in Novo Nordisk Regulatory Affairs.But there are many other really good reasons to apply for a job there. Here are some of them:

“ Working in Regulatory Affairs is an evolving challenge, because while the regulations from country to country change all the time, the patients that you need to treat are always there.”

Nina Veje, regulatory professional

“ I love working for a company that is driven by change. When you start in the job it is one thing, but then a year or two down the line it is something very different: it makes for a fun challenge.”

Gitte Voldum Jovcevski, labelling coordinator regulatory affairs

“ It is really great to be able to work in so many talented teams and achieve goals as a team, which we as individuals never could have done alone.”

Frank Bringstrup, senior regulatory project manager

“ The most rewarding aspect of working in Regulatory Affairs is that what I do helps our products reach the patients and makes their lives easier and better.”

Sandra Gairy, regulatory affairs country coordinator

Novo NordiskWorld Leader in Diabetes

Send your application or questions about Novo Nordisk Regulatory Affairs toJoinRA@novonordisk.com

Read more about careers in Novo Nordisk at novonordisk.com/careers

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy.

Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. Headquartered in Denmark, Novo Nordisk employs more than 27,000 employees in 81 countries and markets its products in 179 countries.

Production sites Bagsværd, Denmark Chartres, France Clayton, North Carolina, US Dely Brahim, Algeria Gentofte, Denmark Hillerød, Denmark Hjørring, Denmark Kalundborg, Denmark Koriyama, Japan Køge, Denmark Mexico City, Mexico Montes Claros, Brazil Måløv, Denmark Tianjin, China Værløse, Denmark

R&D facilities Bagsværd, Denmark Beijing, China Gentofte, Denmark Hillerød, Denmark Måløv, Denmark Seattle, Washington, US

Clinical development centres Beijing, China Princeton, New Jersey, US Tokyo, Japan Zurich, Switzerland

Regional and business area offices

Affiliates

Representative offices

World’s Best Diabetes Care Pipeline

Novo Nordisk has the “Best Diabetes Care Pipeline” in the world, accord-ing to R&D Directions magazine’s ”Top 10 Pipelines” list.

Product AreasDiabetes careHaemostasis management (NovoSeven®)Growth hormone therapy Hormone replacement therapy (HRT)

Novo Nordisk Regulatory Affairs

437 employees in 70 countries

Doubled the number of employees during the past five years

Regulatory Affairs in Denmark is situated close to Copenhagen