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One working day in Alkaloid

Interview with Emilija Davidova


"The Regulatory Affairs Department is instrumental in ensuring that medical products comply with the necessary regulatory requirements prior to market approval. We serve as a liaison between the company and regulatory agencies tasked with issuing marketing authorizations.

Successfully registering a new medical product demands a strategic and systemic approach, encompassing meticulous planning, adherence to regulatory standards, and seamless communication with regulatory agencies. The regulatory strategy outlines the optimal pathway to swiftly and effectively secure the marketing authorization, addressing predefined marketing considerations while ensuring the product's safety and efficacy.

 

Working within the regulatory strategy team amidst a perpetually evolving regulatory landscape entails having analytical skills for interpreting complex regulations and scientific data, along with the ability to identify potential risks promptly and accurately.

I am fortunate to be part of a team where we tackle daily work challenges together through teamwork, knowledge sharing, and a supportive work environment filling my workdays with positive energy." - Emilija Davidova, Regulatory Strategy Preparation Coordinator.