Working with large amounts of numbers and data comes naturally to Elisabeth Schweiberer – a skill she discovered during her studies and which today forms an important foundation of her profession. As a Regulatory Affairs Manager at an internationally active pharmaceutical company, she is responsible, among other things, for phenoxymethylpenicillin. This antibiotic substance - an active pharmaceutical ingredient from the penicillin group - is subject to regulatory approval requirements throughout the entire manufacturing process. Especially in drug approval, every step in the manufacturing process must be documented with extreme precision so that a substance can obtain or maintain approval from regulatory authorities. “Even the smallest change in the process must be documented and reported, even if only the package size changes slightly - and this applies to all our markets: the European Union, the USA, China, Japan, India, and many more,” explains Schweiberer, originally from Hainzenberg, a small village in the Zillertal valley.
Elisabeth Schweiberer keeps track of both minor and major changes to “her” substance: “If process changes in production are planned, I discuss them with colleagues and check the guidelines to determine what impact this will have on the current approval. As an expert in this field, I analyze what we need to provide to regulatory authorities in different countries. For example, if we change the specifications of the active ingredient - such as increasing limit values -this is considered a major change and requires a well-founded justification as well as additional analyses and stability data,” Schweiberer explains. “Ultimately, as manufacturers we guarantee that an active ingredient is always delivered at exactly the same quality - and we must be able to demonstrate this according to strict standards for every batch.”
Practice-oriented training with an international focus
Schweiberer acquired the foundations for her work in Innsbruck. She first studied Molecular Medicine at the Medical University of Innsbruck and then decided to enroll in the newly introduced Master’s program “Pharmaceutical Sciences – Drug Development and Regulatory Affairs.” The English-language program is offered jointly by the Medical University and the University of Innsbruck.
Because clinical studies, data management, as well as drug regulation and approval perfectly matched her interests, Schweiberer was already part of the first cohort of the new master’s program. “After my bachelor’s degree, I had worked in data management for clinical trials and wanted to stay in that field if possible. When a friend told me about the new master’s program, I immediately knew I wanted to continue in that direction,” she recalls. “In this program you systematically learn everything that has to happen for a drug to reach the market,” Schweiberer summarizes. “Experts from international pharmaceutical companies and regulatory authorities gave us a lot of practical insight,” she continues. “Anyone interested in data management in clinical trials will find this program a great fit. And even if you want to stay working in the laboratory, you learn the regulatory background there.” Schweiberer notes that English as the language of instruction gave her a strong foundation for working in an international environment: “Many of the technical terms in this field don’t even exist in German. We also spoke English outside the classroom because several students in my cohort didn’t speak German.” She held her thesis defense in October 2024 - and says she would choose this program again today.
In her free time, Elisabeth enjoys hiking and swimming. The cold water of alpine lakes does not deter her any more than the multitude of numbers and regulations in her professional life. “Some people might find that boring or tedious,” Schweiberer says - but for her work through the many different regulations is an exciting challenge: “I like this precise work on the computer!” In this way, she keeps a focused overview of every detail - always supported by guidelines and by carefully recorded numbers and data.
The Master’s program “Pharmaceutical Sciences - Drug Development and Regulatory Affairs” has been offered in Innsbruck since 2022 as a joint English-language program by the University of Innsbruck and the Medical University of Innsbruck. The program equips students with technical and scientific knowledge in drug development as well as expertise in the regulatory frameworks. Its goal is to train professionals who possess an end-to-end understanding of the pharmaceutical development process and can confidently translate this knowledge into practice within their future career.
An online information session about the Master’s program in Pharmaceutical Sciences will take place on March 18, 2026 at 9:00 a.m. as part of the LFU Master Weeks. Further information: https://www.uibk.ac.at/en/studium/onlinesession/master/
(MedUni Innsbruck/P. Volgger)