Maria Boese, Novo Nordisk A/S – University of Copenhagen

New skills with MIND on board

Maria Boese
Vice President of Regulatory Affairs
Novo Nordisk A/S

Just a few years after qualifying as a chemical engineer Maria Boese has gone from thinking analytically in a lab to thinking strategically as part of the management team of Denmark’s largest and most successful pharmaceutical company.

The Regulatory Affairs function is central to the pharmaceutical industry because it brings together and coordinates all aspects of the drug development process, from preclinical development and clinical trials in humans, to production and pharmacovigilance. From the earliest stages of development of a new drug, it is important to get an overview of the regulatory framework. Which challenges should the company take into account in the development of a specific product? Which clinical trials should be organised for drug approval? Which law applies in an international market? Strategic thinking in terms of risk-benefit analysis and a flair for politics are very important when developing drugs.

“When working with regulation and registration in the pharmaceutical field, it is essential to get an overview of the drug development process. Amongst other things, the breadth of the Master of Industrial Drug Development gave me insight into clinical trials and law, two fundamental aspects of all drug development. At the same time the flexible programme has been a great advantage because I have a really busy life. The short intense courses and freedom of choice has been excellent for me. Most MIND courses last a week with an exam on the last day. It is perfect for busy people with lots to do both at work and during leisure time,” says Maria Boese.

Flair for business and management ambition

Maria is currently vice president of Regulatory Operations at Novo Nordisk A/S. She completed the MIND programme in 2010 and has also taken an HD to increase her business acumen:

“I work as a manager on a daily basis and the combination of training in marketing management and my master’s degree in industrial drug development has given me a strategic overview of business, from a pragmatic drug development point of view. Many teachers at MIND spend their days in the industry - so there is no lack of specific examples in the teaching. The programme has a practical aim, which has been very useful for me. In my management job I work with specialists from all parts of the drug development process and it’s great to be able to participate in academic discussions at all levels. The breadth of the MIND programme is really good for that,” says Maria Boese.

A broad approach to drug development

Regulatory Affairs professionals are usually responsible for checking that product marketing meets the relevant legislation. Marketing permission is based on the evidence in the registration application, which is produced by the company:

“In my job, I rely on drug professionalism every day, this includes documentation of quality, safety and efficacy. Knowledge of legislation and general understanding of society are also things I draw on all the time. As a chemical engineer I needed a broader professional profile in pharmaceuticals to make the transition to regulatory affairs - the MIND programme has been a very important step,” says Maria Boese.