A path from medical biology to regulatory affairs

Dr. Silvia Kluge, Team Leader in Regulatory Affairs

Follow your interests

Dr. Silvia Kluge, Team Leader in Regulatory Affairs, is not your typical manager. A look at her C.V., and you will be impressed: internship at Cambridge University, master thesis at Harvard Medical School, Ph.D. from Ulm University, positions in the pharmaceutical industry. Talking to her, however, and you’ll get a sense that Silvia isn’t just about doing the right things. Instead, you’ll hear words like “passion,” “gut decisions”, “follow my interests” and “teamwork”. We wanted to hear more about Silvia’s path – and why her position at HARTMANN is a fitting culmination of her diverse experiences.

A passion for biology and purpose

Silvia always loved nature, and in school was fascinated with biology, particularly the human body and how it works. Encouraged by her biology teacher to study, she pursued a degree first in Medical Biology. She explains, “It combined all of my interests, but it also allowed for concentrations in areas like molecular biology, medical ethics and virology.” Silvia knew that she didn’t want to be a medical doctor, but still envisioned a profession that had purpose – one that would help people through research.

A student’s life

In her studies in Medical Biology, Silvia gained her first sense of the importance of a team. “The course of study was small, so the professors got to know students well. This really made a difference in the guidance they gave us.” They encouraged Silvia to think big, and she received internships at Cambridge University and Harvard Medical School, where she went on to complete her Master’s in Virology. Her time spent at Harvard Medical School would teach her another valuable lesson – find the place that is right for you. Silvia says, “Harvard was amazing, but also very competitive, everyone working towards their own goals. I missed the commitment to teamwork.” Silvia went on to complete her doctoral studies in a renowned lab at Ulm University where she could follow her interest in virology, in particular HIV.

A deep dive into the industry

After finishing her degree, Silvia jumped feet first into the pharmaceutical industry. She began exploring paths in the areas of regulation, patient data and privacy as well as team building and international cooperation. Many of the skills she had finetuned during her studies came to good use in her professional life. “You have to organize your questions, sort out your answers and like a puzzle, you begin to expand and build a picture of a way forward to a good solution.” Silvia embraced roles where she could tackle problems, analyze and interpret and define, and where she could “learn, learn, learn.” On that path, she sought out her current position in Regulatory Affairs at HARTMANN.

A member of the team

Silvia began working in Regulatory Affairs in 2020. As she points out, it’s a diverse field – and regulations are crucial to ensure products are safe and effective. She oversees, among others, aspects of product life cycle management, and change control management; first and foremost from the perspective of regulatory compliance in Wound Care. As a Team Leader, Silvia draws on her past experiences where she learned the value of a team that works together. She explains, “I’m one of the team and when we are in a tight spot, we work side by side and do what needs to be done. I really appreciate that we can debate with each other and stand up for each other.”

What does she enjoy most about her job? “The detective work. Working with people who can use structured thinking to take apart processes, put things in a logical order, and defend solutions.” Looking at the product pipeline and seeing that legislation is a constantly evolving field, in which new regulations, directives and guidance documents are constantly arising, the team will have no shortage of challenges in the future!

Silvia says she’s had good role models in the past and particularly at HARTMANN and appreciates how much teamwork is supported here. She explains, “HARTMANN’s Fit to Lead program allowed me to learn so much about Leadership, about working with different personality types and bringing out their potential.” HARTMANN’s program also gave her additional training to become a certified ‘RA Manager International’.

A part of HARTMANN

Silvia remembers the first time she walked through the doors of HARTMANN, “Everyone said ‘Good Morning’ or ‘Hello’ regardless of whether they knew each other.” After several years at HARTMANN, Silvia has a continued sense that the company is really made up of its employees – it’s more than a logo. “HARTMANN is us,” she says. And in her job in Regulatory Affairs, she’s found the purpose she envisioned for herself when she first started out – a job that helps people.