In this article we shine the spotlight on Hildegard Schmatz. Hildegard has been with NDA since 2009 and she specializes in European regulatory procedures including linguistic reviews and lifecycle activities, regulatory project management as well as regulatory planning and QC management. Hildegard also leads activities for several non-European countries.


When comfort is uncomfortable

The definition of an ’adrenaline junkie’ describes a person who feels a compulsion to take part in exciting, dangerous, or intense activities such as sky diving, canyoning or ice climbing. According to Hildegard Schmatz, thrill seeker and senior consultant at NDA, regulatory affairs can be equally intense and exciting which is the fundamental reason why she loves her job.

Hildegard started her career as a pharmaceutical technician and after six years in public pharmacies, she felt ready to take the next step and joined the pharmaceutical industry. She has now been working with Regulatory Affairs and Quality Assurance for 25 years. However, thinking back to her first position at a small generics company Hildegard admits that she had no prior knowledge in Regulatory Affairs when she started.

“I started at the bottom with easy undertakings and tasks that quickly developed into more and more sophisticated responsibilities, she explains. “I also had the good fortune of having a remarkable supervisor who mentored me and encouraged me to take on challenges in a very pragmatic way”.

The position, however, involved working only towards national competent authorities so when Hildegard got an opportunity to work in Regulatory Affairs at the European Headquarters of a global pharmaceutical company, she took it. A couple of years and several coincidences later led to Hildegard and several of her colleagues to NDA.

“When the pharma company I was working for moved their headquarters abroad some of us stayed in Germany and this resulted in NDA opening a local office in Munich” she explains. “From the beginning the German NDA office was entirely made up of old colleagues, but we have grown since then and new colleagues have joined so now, I would say it’s fifty-fifty”.

Being a People Person

Hildegard thrives on working closely together with clients.

“I am very lucky”, she declares. “I have almost never felt that I’m an external consultant, my clients always make me feel like part of the team and their ‘baby’ also becomes my baby”.

New regulations, new companies and new ways of working keep Hildegard on her toes. Whenever she encounters a new challenge or question, her first reaction is ‘That’s a valid point, let’s see how we can manage that’.

“The most important asset in this job is to love working with people”, Hildegard explains. “People are different, they have different education and approaches, and different starting points. And you never know what kind of pressure they are under. I love working with people and always try to keep that in mind”.

Making the adrenaline rush

With her long history in the regulatory field, Hildegard knows that nothing is set in stone. Regulations and guidelines are based upon previous experiences and there are always ways of doing things differently. So, for a particular client, in a particular situation, these particular requirements are applicable. As a regulatory consultant, this is where you need to be innovative and experienced enough to see things in a new way.

Hildegard also knows that people react differently when under pressure. Some people become nervous, some agitated. Hildegard stays calm and asks herself the most critical questions; what is the first step we must take to put the fire out? What is the next step? And the next? One step at the time, is the best way to get through any kind of breakdown, and of course always ask for help!

“I work in a secure environment where I know that I can just pick up the phone and get some input on my options”, she says.   

Hildegard is at her best when project managing, keeping everything together and moving in the right direction. Especially the last few weeks before a big submission, all her focus is on having the right information before pressing the send button. Fortunately, she has a loving line-up of family and friends that support her during pre-submission late nights.

“This is how I am”, Hildegard says. “I need the pressure. It is a special feeling to see everyone doing their very best to bring about the submission, to see true teamwork in action”.

The final weeks are supposed to be hectic. If they’re not, then alarm bells start ringing.

I once had a submission that went so smoothly that I couldn’t shake the feeling that I had forgotten something”, she says with a laugh. “I had to go back and double check the submission plan, that’s how rare this situation is”.

And since smooth submissions are less common, it is a good thing that Hildegard thrives on the more chaotic ones.

About

Hildegard Schmatz

Senior Consultant

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