Alisa Falkova
Director Regulatory Affairs (Uk, Ireland) @Edwards Lifesciences
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WORK HISTORY
Director Regulatory Affairs (Uk, Ireland) @Edwards Lifesciences
Newbury, GB
EDUCATION
Bogomolets National Medical University
MD, Stomatology
ABOUT ALISA FALKOVA
Regulatory Affairs professional with 8 years of experience in pharmaceutical industry and 5 years in medical devices. Strong regulatory background includes specific expertise in Regulatory Affairs, regulatory compliance and submission experience, SOP preparation. Demonstrated analytical and communication skills that encompass identifying critical concepts, solving complex problems, presenting complex ideas in a clear, concise and persuasive manner and keen attention to detail. Proven ability to effectively manage time and multiple projects, contribute effectively to global cross functional teams, achieve deadlines and collaborate with colleagues on a global level. Key Skills: regulatory documentation, handling documentation related to drug registration, regulatory strategy, responding to queries of health authorities, pharmaceutical product registration, dossier compilation, regulatory compliance, labelling compliance, internal audits, sop preparation.
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