“Plan ahead and tackle tasks early. Do things right the first time” – Dorit Jacob, Regulatory Affairs Director
I have been working at NeuroSense for a year and a half now. I have had experience in both big and small companies throughout my career, but I have ultimately decided that small companies are more “my thing” as it gives you the option to work with colleagues from different teams such as quality, non-clinical, clinical and R&D. I find the work at NeuroSense very interesting and fulfilling, especially as we, at NeuroSense, truly care about the patients. We understand the complexity of the disease and how difficult it is for patients and for their families. This disease has such a high unmet need, and the real challenge is to bring the product to market as soon as possible, without compromising on its quality.
At NeuroSense, I am the Regulatory Affairs Director. I am the interface between the regulatory health authorities and the company. I interpret the guidelines, provide clarity to NeuroSense on what is required and ensure cross-functional compliance with these requirements.
In my role, I handle direct communication with regulatory authorities. Transparency with these agencies is crucial. I lead and facilitate the preparation of information required for submissions and drive regulatory strategies. Each document is meticulously crafted, reflecting its importance to our company’s compliance and success.
Throughout clinical studies NeuroSense conducts, I oversee that the regulations are being followed and I am constantly updating files for submission to the authorities. For example, when amendments are made to the protocol, I play a role in making sure that the changed protocol still complies with all necessary regulations. I document what, why and how we did it, in order to describe our case as I submit the information to the agency.
In order to effectively handle all regulatory aspects, it’s essential for me to have a thorough understanding of both current and past developments within the company. This requires meticulous organization and excellent memory skills, which I bring to the table. My ability to keep detailed records and swiftly recall relevant information allows me to manage challenges efficiently and respond accurately, ensuring the smooth progress of our projects.
My professional tip is to plan ahead and tackle tasks early. Do things right the first time, focus on quality and precision from the start to avoid costly mistakes and enhance efficiency.
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