Обязанности:
Pharmaceutical Affairs Director, EAEU Qualification: Science education, preferably pharmaceutical. Additional benefit may be law degree or practical experience in pharmaceutical sciences related to the preclinical and/or clinical studies, or medicines’ pharmaceutical development, or quality assurance/quality management, or pharmaceutical manufacturing background, or scientific academic degree in the abovementioned disciplines. Working experience in pharmaceutical companies for at least 5 years as the RA Director/Pharmaceutical Affairs Director, Medical Director or other leadership position with similar duties. Focus on regulatory processes’ management with knowledge of relevant Russian/Eurasian pharmaceutical regulation. Understanding of ICH principles and contemporary international pharma approaches. Knowledge of the principles of European pharmaceutical regulation and the main differences among USA/European/Eurasian/Russian pharmaceutical requirements & principles. Excellent management skills, talent to Inspire and motivate the team. Strong sense of team spirit and cross-functional cooperation approach. Transparency and willingness to share. Fluency in English, French will be an advantage. Main duties: To lead and oversight that Regulatory Affairs, Medical Review, Pharmaceutical Projects divisions of the Pharmaceutical Affairs Department meet strategic and operational goals of group, as well as continue to provide the value and benefits within the scope of the respective disciplines to the Pharmaceutical/Regulatory Affairs of others Eurasian member-states (Armenia, Belorussia, Kazakhstan); Advice and assistance from a scientific and pharmaceutical point of view for all the Group's departments. Develop multi-functional collaborative relationships across business units, global divisions, and project teams. To initiate and monitor the development & updates, to validate strategic planning of Marketing Authorizations (MA) actions (filings, answers on the questions, approvals, renewals, variations in referent country and in concerned member-states, finalization of EAEU alignment in Armenia, Belorussia, Kazakhstan, Kyrgyzstan); EAEU Good Manufacturing Practice (GMP) inspections for MAs approval/renewals/variations, for manufacturers located out of EAEU; To write letters to the Federal authorities of public health (except MA, GMP inspections applications, other practical issues). To check, correct and/or approve the letters to the authorities, drafted by PharmaAffairs Team; Provide tactical and operational planning, work plans and budgets of the Department; controlling document flow related to regulatory budget execution; Organization of JSC «Servier» coordination of pharmaceutical responsibility (relative to the group Servier corporate procedures, being the basis for national JSC «Servier» respective SOPs). Changes implementations: needs in the processes/documents updates within the results of self-inspections, review of CAPA (corrective and protective actions) execution, new SOPs or SOPs updates approvals, etc.Похожие вакансии
Договорная
Москва. Станции метро: Белорусская
Envista Holdings Corporation