Nicoleta Spinu

Hey, thanks for checking out our team! It looks like this team member has left us in the meantime. We generally part ways on good terms and are not one of those companies which make ex-colleagues magically disappear from their website, so you can still check out their profiile here! :)


Throughout my initial studies in Pharmaceutical Sciences, I developed a passion for regulatory affairs. I followed several internships and programmes that enabled me to gain practical experience. I even chose to write my Master’s thesis on a topic related to pharmaceutical legislation.

However, I was always in between research and regulatory affairs. Science is a place that allows me to be creative and that subsequently led me towards developing an interest in computational modelling. Legislation and policy decision-making taught me to be pragmatic and think strategically about a problem.

Both made me understand why it is challenging for the regulatory authorities to keep pace with the innovation. On the other hand, bridging the gap between the early-stage start-ups and the market should not be a coin toss opportunity. An AI solution is mainly about data, models and computational infrastructure. With a tailored regulatory strategy, any start-up should be able to comply with the regulatory requirements and be an added-value to the healthcare system. That’s one of the million reasons for joining OpenRegulatory along with the shared vision and values, to help others that can improve and have a positive impact on a patient’s life.

My role herein covers helping with medical writing as well as the FDA certification but not limited to.

See you around! 🙂