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Science Made Me help bring safe and efficacious medicines to patients
Dalena and her colleagues in Regulatory Affairs play a crucial role in bringing innovative medicine to patients. Before a product is launched, it undergoes an extensive development programme to confirm its efficacy and ensure its safety. The data obtained is prepared by our experts in Regulatory Affairs and presented to regulatory authorities like the US Food and Drug Administration (FDA) that decide whether to approve the new product.
Two main roles
For Dalena, her role comprises two main functions. "One is on the research and development side. I help ensure that our company's products meet the expectations of the US FDA and the set of laws that the US has." And then there is the commercial side of her job. Grünenthal wants to help as many patients as possible to improve their lives, and "people have to know about our products. Part of my job is ensuring that the advertising is truthful and meets all the FDA regulations."
It takes a village
Everyone experienced pain at some point in their lives. One of the learnings Dalena had when joining Grünenthal was that there are many different types of pain. While most people experience a headache and know there is a medicine to help with that, there are many other examples where the problems aren't easy to fix. A formative experience for Dalena was a tooth issue. "The doctor prescribed an opioid. It made me so nauseous that I had to stay in bed all day. So instead, I lived with the pain." Today, this experience still drives Dalena and enables her to relate much closer to her job and Grünenthal's purpose to research and develop innovative pain medicines. Bringing such products to patients is a challenging but very rewarding task. "It takes a great team to accomplish what we are working on. We are so interconnected with how we work because of government oversight. Generally, I'm not making decisions on my own. I am checking with my counterparts in different functions and aligning to ensure we have missed nothing."
Commitment beyond business
When she is not leading the way in the pharmaceutical industry, Dalena likes spending time outdoors. Born, raised, and living in the Garden State, New Jersey, it's not surprising that Dalena loves gardening, but there is more to it. "You know, with gardening and my job too, I think what's most important to be successful is patience and problem-solving skills." Dalena even has a small garden of chilli peppers that ties into one of Grünenthal's products. Its active pharmaceutical ingredient (API) "is a synthetic form of capsaicin, which the natural form comes out of Chili Peppers. […] It's fascinating."
Want to read more stories about our scienticsts? Check out the stories of Sevil Davidson, Maria Stupar, and Sarthak Sharma.
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