Specialist in regulatory management in YuRiYa-FARM, Farmacevtichna Korporaciya

YURI-PHARM is a Ukrainian pharmaceutical group of companies that owns the largest area of ​​production facilities in Ukraine. We operate in more than 50 countries around the world and have ambitious goals of entering the TOP 100 global pharmaceutical companies. Today, in the conditions of martial law, without stopping for a single day, we continue to provide both the civilian population and the Armed Forces with essential medicines and medical products. We invite an expert in regulatory management to join the team. We offer: official employment; competitive salary and annual bonus based on work results; safe and modern office, free meals; laptop, corporate mobile communication; annual vacation of 30 calendar days instead of 24 KZpPU; material assistance in various life situations; career growth and corporate development programs. Main tasks: development and support of a plan for the implementation of a new operating procedure within the Directorate of Research and Development, taking into account compliance with regulatory requirements for the appropriate type of pharmaceutical product; analysis of regulatory requirements of prospective markets sales for the products of "Yuriya-Pharm" LLC, which may have an impact on regulatory management; control of the correct functioning of the operational procedure within the Research and Development Directorate and compliance with the rules of their management by the responsible specialists; collection of information on malfunctioning of the operational procedure within the Research and Development Directorate; formation Standard Operating Procedures and Business Process Instructions within the Directorate of Research and Development, which were subject to revision or formation by a specialist in regulatory management according to ISO 9001. Necessary knowledge and skills: ISO 9001 and related standards. Quality management Resolution of the Cabinet of Ministers of Ukraine dated October 2, 2013 No. 753 "On approval of the Technical Regulation on medical devices"; Law of Ukraine "On Medicinal Products" dated April 4, 1996 No. 124/96-VR; Order of the Ministry of Health of Ukraine dated August 26, 2005 No. 426 "On approval of the Procedure for examination of registration materials for medicinal products submitted for state registration (re-registration), as well as examination of materials on making changes to registration materials during the validity of the registration certificate" with changes; other instructions of the Ministry of Health of Ukraine , the State Expert Center of the Ministry of Health of Ukraine, the US Food and Drug Administration (FDA) and competent authorities of other countries. higher pharmaceutical education or education in the field of standardization, metrology, certification, quality assurance; work experience in the field of standardization, metrology, certification, development quality assurance and/or production - at least 1 year (preferred); intermediate level (possibility of working with English-language documents and writing documentation in English); Life is the main value on earth. Join our team to create unique solutions, thereby preserving and improving it!