Expert (chemist) of the Department of Bioavailability and Bioequivalence Materials

Job duties of the expert position:

• Conducting expert evaluation of registration materials on bioavailability / bioequivalence of medicinal products for state registration / amendments to registration materials;
• Conducting expert evaluation of materials of clinical study protocols for assessing bioavailability and/or bioequivalence or substantial amendments to these protocols;
• Participation in drafting regulatory documents, legislative acts, and instructions, and in amending and supplementing them;
• Participation in organizing and holding seminars, conferences and other events on bioavailability and/or bioequivalence;
• Continuous improvement of one's professional level, study of regulatory and legislative documents on matters within the competence of the department;

Requirements for candidates:

• Higher education (chemical, biotechnological, chemical-technological, pharmaceutical);
• Experience in pharmaceutical development of medicinal products and/or preparation and expert evaluation of registration dossier materials, quality control, quality management, experience in the field of development
• of medicinal products and/or preparation and expert evaluation of registration dossier materials (not assembling registration dossier materials for submission to the Center!);
• Understanding of technological processes of pharmaceutical manufacturing and quality control processes;
• Knowledge of analytical chemistry and chromatographic methods of analysis;
• Confident PC user: MS Office, PowerPoint;
• English at Pre-intermediate level or higher (understanding of medical literature and terminology);
• Organization, a high level of responsibility, ability to learn quickly, ability to work independently and in a team, ability to process a large amount of new information, punctuality, ability to work attentively with documents for a long time;
• We also consider university graduates with an education in chemistry, biotechnology, chemical technology, or pharmacy.

Working conditions:

• We consider veterans and persons with disabilities and are open to employing them.
• Working hours: Mon.–Thu. from 09:00 to 17:30, Fri. from 09:00 to 16:30;
• Official employment under the Labor Code, 31 day(s) of leave, sick leave;
• 5-day work week with the option to adjust the schedule to your needs;
• Good team and management support;
• An adaptation period and job descriptions according to which one can work;
• Training and assistance during the probationary period and whenever such a need arises.