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Growing with Fresenius Kabi: A Career Path in Regulatory Affairs, Quality and Vigilance

How Yenna Vandevijver grew responsibilities, expertise and leadership over 15 years

Some careers start with a clear plan – others with a willingness to learn. When Yenna Vandevijver joined Fresenius Kabi in September 2011, shortly after graduating as a pharmacist, she was at the beginning of a long-term career in Regulatory Affairs. She knew she wanted to work in the pharmaceutical industry but was still exploring where her strengths and interests would take her. Fresenius stood out overall, and Fresenius Kabi in particular for its broad portfolio and its impact on patients’ lives. Fifteen years later, her perspective hasn’t changed: I started here in my very first job, and learning has been a constant part of the journey ever since.

How did Yenna Vandevijver’s role grow over time without changing departments?

Yenna’s story is not about one big career move, but about responsibility added in layers. She began with core Regulatory Affairs work, mainly the local review and approval of labelling documents and the submission of variations to the registration file in Belgium and the Netherlands. 

Over time, responsibilities within the role expanded step by step. From April 2013 onwards, this included safety‑related activities in the BENE countries as National Safety Officer, covering pharmaco- and materiovigilance, as well as responsibilities related to information and publicity, approving local marketing material. 

In March 2014, Yenna took on Good Distribution Practice responsibility for Belgium and the Netherlands and qualified as an internal auditor, further strengthening the connection between Regulatory Affairs, Quality and patient safety.

Image of Yenna Vandevijver.

She also links her own role development to how the RA/QA department itself has evolved over the years: “During my 15 years at Fresenius Kabi, I have seen the department grow and evolve alongside its increasing responsibilities, developing from a small team of three into the dynamic, multidisciplinary team we are today. It reflects the growing complexity and importance of regulations, quality, good distribution, and post marketing surveillance. Combined with an expanding portfolio, this brought continuously new challenges, projects, and opportunities to grow.”

In recent years, the scope of her role also expanded to include people leadership, first as a Regulatory Affairs & Vigilance Manager in January 2023 and since September 2024 as RA/QA Director. She now leads and guides the Regulatory Affairs, quality and vigilance department within Benelux, and contributes to the local management team. Reflecting on that journey, she says: “I’m grateful for the growth I’ve experienced over the past 15 years and for the support Fresenius Kabi has given me. Starting as a recent graduate, I was given the trust, support, and opportunities to grow, allowing me to develop step by step within the organization.”

Image of Yenna Vandevijver with team.

What makes Regulatory Affairs and Quality work at Fresenius Kabi in Benelux unique?

Yenna describes the Benelux environment as diverse and dynamic. Across Benelux, the work spans pharmaceuticals, medical devices, enteral nutrition, and biosimilars, each with its own regulatory and quality landscape. She also notes that being part of a smaller marketing unit allows roles to combine responsibilities across Regulatory Affairs, Quality Assurance, vigilance, and medical tasks, making the work varied and engaging. She describes the Benelux Marketing Unit as a warm and supportive environment, where colleagues work closely together, openly share knowledge, and where professionalism goes hand in hand with genuine moments of shared laughter and joy.

What is it like to work in such an internationally connected company like the Fresenius Group?

Working across three countries, with different authorities, languages, and expectations, is both challenging and rewarding, and it keeps the work full of continuous learning. As part of the Fresenius Group, this also means that local work in Benelux is connected to a broader organization, bringing in different perspectives and ways of working.

What does Regulatory Affairs and Quality work mean for patients, even behind the scenes?

In her department, the team ensures that every product distributed holds the correct licenses and is handled and distributed in full compliance with safety and quality requirements, with a focus on post marketing surveillance. They collaborate with many stakeholders, from authorities to healthcare professionals and external partners, and she describes teamwork as an essential link to delivering high quality products to patients. As Yenna puts it, “Even though our work often takes place behind the scenes, we act as a local guardian ensuring that high quality products reach the patient in the right way.” For her, staying in the same department did not mean standing still. “Sometimes, staying is not standing still, it’s growing deeper, stronger, and further than you imagined.”