Irina Golovacheva, MD, Manager, Regulatory Affairs, Russia
Dr. Irina Golovacheva oversees the regulatory process from the initial study submission and receiving an approval up until end of study notifications for each project conducted by GCT in Russia. Irina is located in Moscow, within easy reach to the Ministry of Health and other agencies. Her responsibilities comprise of filing necessary applications, ensuring control of all Sponsor’s study documents to be submitted to the state regulatory bodies, and further – handling all interactions with MoH, Rosdravnadzor (Federal Service for Surveillance in Healthcare) and other authorities. Irina dedicates a fair share of her time for research to stay on the cutting edge with changes in the clinical trials regulations, combining it with regular participation in industry trainings and official seminars on the same topic. These facts, put together with her critical thinking ability and detail-oriented approach assure 100% successful regulatory track record for GCT and our Sponsors.
Dr. Golovacheva has extensive background in the Russian healthcare and pharmaceutical industry. Previously, she held positions in Regulatory Affairs and Pharmacovigilance for local CRO and Pharma companies and prior to that was involved in scientific research at the “Scientific Centre of Children Health” institution under the Russian Academy of Medical Sciences for almost a decade. She graduated with a medical degree from Moscow Medical Academy n.a. I.M. Sechenov, the oldest and the largest national medical higher educational institution in the Russian Federation.
When I came to work at GCT, I was impressed by the highest professionalism and team spirit of employees. Solving complicated problems, achieving goals, the ability of each team member to perform various functions is an integral part of working at GCT. Thanks to the experienced GCT team our customers can be confident that all tasks will be performed in high-quality and on time. Employment at GCT gives me the opportunity to improve my knowledge and skills. Every working day presents new, sometimes seemingly unattainable goals and objectives. The most valuable experience is acquired by reaching them. As a Regulatory Manager, each time I respond to a customer request, solve complicated issue, often get an approval for a new clinical study ahead of schedule, I experience the unforgettable feeling of the goal achieved, keeping in mind that our main purpose is helping the patients.
Apart from Russian, her native language, Dr. Golovacheva is fluent in English and speaks some Serbian. One of Irina’s main roles in life is being a mother and she loves to spend free time with her son, playing together, singing, and allowing him to teach her hip-hop and street dance style moves. Besides, Irina enjoys long high-speed bicycling with her friends and other fitness activities. A different and exotic hobby of hers is aquarium husbandry, with a special interest towards aquarium design.
Updated: September 12th, 2016