Making a real difference for patients
Meet Katrin Fleischer
Head RA Global Portfolio
I am a biologist by training and completed my Ph.D. in 2004. Up to that time I was a successful research scientist. I felt, however, this not to be the field I wanted to be working in for the rest of my life. I am a generalist, not a specialist. I understood different disciplines on a high level, liked working in teams and felt that I had a talent for bringing different disciplines together, finding compromises and building bridges.
When I started my postdoctoral fellowship at Sanofi-Aventis, I learned about the variety of opportunities in the pharmaceutical industry outside research and applied it to respective job offers at different companies. Unfortunately, no company was willing to hire me outside my expertise – research. Grünenthal did. They gave it a try and hired me for a job as regulatory affairs manager even though I had no dedicated experience in that field.
At Grünenthal I started on a supporting position in the lifecycle management group within Regulatory Affairs. Soon, my line managers noticed the fast development and handed me more responsibility. In less than two years I was offered the opportunity to switch to the development group in Regulatory Affairs. There, I led in the team responsible for the development of Tapentadol (Palexia®), the priority 1 development in Grünenthal at that time. I was responsible for the submission of the European marketing authorization application of Tapentadol. It was the biggest submission for Grünenthal in a decade; it was a huge dossier, as at that time still paper copies were required, a logistical challenge.
“There is room at Grünenthal for personal development beyond regular pathways.”
I often had to deal with challenges. As an example, in March 2010, when a dedicated date was agreed upon with the authorities for submission of the final response documents, the Icelandic volcano Eyjafjallajökull erupted and thereby disrupted all air traffic across northern Europe. The dossiers were already on their way to the authorities but then got stuck at different airports. In order to keep to the agreed-upon timelines and maintain our slot available with the authorities, we had to print all dossiers again and send them via ships and trucks. This was only possible because of our team’s “we-can-do mentality” who gave everything possible to reach our goal. Even people who were not part of the core team jumped-in and helped.
Another interesting highlight of my career was the European scheduling of Tapentadol. Tapentadol was the first new chemical entity with narcotic properties that entered the European market. Grünenthal recognized its responsibility as a pharmaceutical company to ensure that adequate control measures for this substance were in place. We proactively sought the discussion with the relevant authorities. I was leading these discussions at the time. Many authorities were not prepared to initiate appropriate control as a proactive measure; in many countries drugs only get scheduled after a problem with abuse has occurred and not proactively prior to an abuse problem. Our discussions even led to changes in law in some countries to enable proactive control measures and also to pave the way for tracking substances at other companies. It was a very interesting challenge and pioneer work for us as a company but also for the authorities.
A few years later, after many other interesting projects within Regulatory Affairs, I gave birth to my son. After a year of maternity leave I re-started my career in Regulatory Affairs. Grünenthal supported my coming back to work by providing a place for my son in the Grünenthal kindergarten close to the Grünenthal campus and my office.
Being part of a team that will hopefully bring an effective treatment to patients with a high, unmet medical needs is very rewarding. It is really great that I have the possibility do this responsible job part time, allowing for the right balance between my career and my family life.