Our Chairwoman for Regulatory Affairs: Heike Wachenhausen

Our Chairwoman for Regulatory Affairs: Heike Wachenhausen

As a lawyer specializing in regulatory affairs for the pharmaceutical and medtech industry, Heike Wachenhausen is well-known in the North for her passionate work and straightforward thinking. In September 2021, she was elected as honorary chairperson of the industry association Life Science Nord. In her new role, she especially wants to be a strong voice with regard to new local or national legislation relevant for the health sector.

Who is Heike Wachenhausen?

When Heike Wachenhausen gets something in her mind, she does it. Straightforward and always looking ahead, that’s her philosophy in life. “I can make up my mind and I am a quick decision-maker,” says the 53-year-old lawyer. The decision to take on the honorary chairpersonship of the Life Science Nord association was not difficult for her either. “We as women, in particular, have to accept responsibility when it is offered to us.”

Working with the former chairman Mathias Kraas, Olympus Surgical Technologies Europe, Wachenhausen spent several years in the cluster’s Regulatory Affairs working group which she helped to set up ten years ago. It would never have occurred to her to take on the job of chairing the organization one day. “In 2020, I was in the process of rethinking some of my existing tasks and jobs: an honorary professorship in Marburg, work on a commentary in the field of regulatory affairs. I handed them over to younger colleagues and wanted to have more time for myself, my private life and new challenges,” she recalls.

Lawyer for regulatory affairs with own law firm

In a career spanning more than 20 years at the University of Göttingen, several business law consultancies and the pharma industry, she finally founded her own business law firm in Lübeck ten years ago – with other female lawyers. Today, the firm is one of the top addresses for regulatory affairs advice in the field of pharmaceuticals and medical products. Companies from both sectors are included among her clients, and the EU Medical Device Regulation in particular has generated a surge of further inquiries in recent years. “The fact that I would get back to a new voluntary job so quickly in autumn 2021 came as a surprise to me, too. Mathias Kraas asked me whether I had really thought about it carefully. But making a difference at the interface between life sciences and policy making appealed to me and I thought it would be great to change something myself.”

A woman who gets down to business

It goes without saying that Wachenhausen will not only want to fill her new position on paper. She is a woman of action, for whom no mountain is too high, no journey too far. She may face challenges in her private life as a passionate hiker or in her career, but none that cannot be mastered. Wachenhausen has already climbed glaciers high in the mountains (such as the Himalayas) and conquered 21,000 meters altitude in a five-weeks-journey by foot from Munich to Venice (in summer 2021) with her husband.

Heike Wachenhause is pursuing strong goals for the future of Life Science North and herself. © Wachenhausen
Heike Wachenhause is pursuing strong goals for the future of Life Science North and herself. © Wachenhausen

Climate change, sustainability and digitalisation: major goals for Life Science North

Now she wants to bring her passion for tackling things into the Life Science Nord Cluster. “I would like the cluster to become even more of a driving force for new projects and legislative proposals – both at regional and national level. I want us to be perceived as a lighthouse in the North, with our own opinion and a strong, competent voice,” says Wachenhausen.

Making a difference at the interface of life sciences and policy making appealed to me.

Heike Wachenhausen
Wachenhausen Dienemann Rechtsanwälte – Lawyers for Life Sciences

Many topics that need to be addressed under the umbrella of the healthcare industry and life sciences are already going through her mind:

  • climate change,
  • sustainability,
  • and digitization.

At the same time, a close connection to the Life Science Nord members and their demands are important to her as well. “Of course, we will need to focus on our strengths and should not get lost in too many general challenges,” she points out.

Cooperation through local solidarity

Down-to-earth thinking and focus are qualities she learned at home as she was the first one in her family to study at university. “When I was 17 years old, I decided to go for legal studies after school. It was maybe a bit naive at the time, but I made it all the way through and never regretted taking that step.” Today, although Wachenhausen does not originate come from the region – she grew up on a farm near Kassel – she is increasingly rooted in the North. Above all, the link between local stakeholders and fostering young talents has been on her agenda for a long time.

Since 2017 Wachenhausen has been honorary professor in the applied natural sciences department at the Technical University of Lübeck and she was instrumental in setting up the regulatory affairs master’s course for which the second class finished its studies at the end of 2021. She believes educating the next generation will be key for the North. “We need close collaboration between industry, business, authorities, and universities because finding qualified employees is currently among one of the greatest challenges facing us.”

Text: Sandra Wirsching

Featured image: © Wachenhausen

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