Regulatory Affairs Manager

компания "российский фонд прямых инвестиций" job overview: under general supervision, prepares, collects and/or reviews regulatory submissions documents for marketing authorization activities either locally or internationally. provides regulatory support and management for assigned projects. essential functions: registration dossiers preparation for the submissions, variations and renewals and their submission to the competent national regulatory authorities; taking the necessary measures to ensure compliance with the planned timing of product registration, renewal and variations traded products; provides operational support and cooperation to the manufacturing sites/cmos to ensure the wellbeing of registration procedures and the best possible project outcomes (business correspondence, regulatory strategy, timely informing etc.); establishes relationships with many partners (manufactures, officials, consultants); meet face to face without rest of team to discuss regulatory issues and present lessons learned. adopts a proactive and flexible approach to resolve any issues, manage meetings with regulatory agencies; identifies project needs, tracks project timelines, implements partners requests and manages day-to-day workload in collaboration with senior staff, as appropriate; actively participates in project teams with internal and external partners independently and communicates confidently in straightforward matters; support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative; technical writing to complete regulatory and/or technical documents to ensure complete and high-quality regulatory deliverables; communicates regulatory issues and opportunities to partners; and provides strategic regulatory guidance to project teams. performs other tasks or assignments, as delegated by the senior management. qualifications: masterchr(39)s degree in chemistry / biology / medicine; fluent english (spoken and written); at least 2 years relevant experience; good understanding of gxp (gmp, gcp, glp); proved experience of implementing at least one of gxp guidelines; good understanding of the research and development process (chemistry, manufacturing and controls/ lifecycle maintenance/ marketing authorization transfers/ labeling/ publishing as applicable); strong knowledge of ctd format for the registration dossiers, good skills at preparation of the technical documentations; knowledge of the eaeu legislation connected with drugs registration and regulation; solid interpersonal communication (oral and written), organizational and analytical skills; ability to establish and maintain effective working relationships with coworkers, managers and partners; ability to work on several projects, with direction from senior staff as appropriate; ability to make adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; stress-resistance, readiness for overwork and irregular working hours.