Pandemic challenges and agile processes in regulatory affairs with Florin Muraru

With a career spanning over two decades in the pharma industry, Sarah Pawar from the BioTalent team caught up with Florin Muraru, a Regulatory Affairs executive with exposure to all steps of the registration process for pharmaceutical products, including CTAs, CP, MRP, and national submission.

Florin has more than 12 years of cumulated experience in the regulatory aspect of product development, and has notable experience developing and managing regulatory teams — in his last role, he made a major contribution to the successful implementation of an innovative Regulatory Hub model service.

During this episode, we touched on the challenges that the global health crisis has created, how the regulatory landscape has enabled its processes to remain agile, and the impact the pandemic would have throughout 2020 and onwards. Florin believes his passion for regulatory affairs is based on the fact that he has the ability, based on clear rules, to deliver an accessible product that provides medicine as fast as possible to patients, doctors, and clinical specialists.

Florin discusses the importance of using your knowledge to adapt to the climate, support products and therapies, adhere to regulatory guidelines, assist with the development of the product, and address, solve and overcome challenges promptly. There are challenges every single day, with the unprecedented crisis creating many problems but also new, unfamiliar obstacles — one of which includes the level of communication and the way discussions are presented to ensure they’re understood when considering a good, strong, scientific argument for registering a new product or regulatory strategy.

The ability to adapt to the current climate is of utmost importance. A lasting realisation for Florin is that there is no interest in profit within regulatory affairs; individuals in his field are commonly interested in the health and safety of their patients. The world and industry reacted rapidly to the pandemic, showing us that healthcare professionals will not sacrifice the quality of care over profitability. The lessons learned in the first wave of the pandemic create a future based around enhanced collaboration and the agile development of future products and therapies.

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