Regulatory Affairs Director/ Директор по регистрации (лекарственных средств)

Responsibilities: Perform competence and skills development, assessment and motivation of the employees of RA department; Develop, maintain and monitor regulatory strategy in Russia, Kazakhstan, other CIS; Monitor and evaluating regulatory trends and requirements, developing an appropriate regulatory strategy and action plan; Assess potential impact of new regulatory requirements on recommended risk-management plan; Establish, maintaining and developing relationships with regulatory authorities, both in the industry and among professional associations; Development and implementation of frameworks, policies, procedures; Organize all regulatory activities, including product registration and post registration maintenance and provide other departments/third parties with relevant information/recommendations with respect to Regulatory Affairs matters; Ensure that submitted documents comply with the company requirements and regulations of health authorities; Organize dossiers’ preparation as well as timely submissions and approvals in accordance with approved work plan of Department; Liaise with and report to Tevachr(39)s local, Regional and Global management units to ensure that multiple priorities are aligned and relevant information/results are shared; Proactively share and apply policies/approachess cascaded by Region/Global units and ensure best Regional/Global practices are applied where it is possible; Develop multi-functional collaborative relationships across Business units, Global/Regional divisions, and project teams; Organize tactical and operational planning, annual, semi-annual, quarterly and monthly work plans and budgets of the Department; manage regulatory budget planning & execution in accordance with internal company policies, prepare regular performance reports on RA Department. Requirrements: 5+ years experience in the similar role; University degree of Pharmacy/Medicine Experience in managing a cross functional team, outstanding leadership and partnering competences; Advanced analytic and structured problem solving competences; Well-developed business management, negotiation and customer relationship building skills; Strong convincing, communication and customer relationship skills Solid knowledge and experience of regulatory legislation, industry standards and guidelines in Russia, Kazakhstan, other CIS with respect to medicines, food supplements, medical devices, cosmetics Fluent in written and spoken English High ethical standards and personal integrity