Head of Regulatory Affairs & Drug Safety Директор по Регистрации и Безопасности ЛС

З/П договорная
Размещено 12 февраля


Требуется head в г. Москва. Responsibilities: To lead RA (product registration, renewal, variations in line with timeliness, SOPs and local regulation in Russia) Quality control: post-approval controls, certification Team management Clinical trials submission/approval in FGU Roszdravnadzor Price registration Bar codes registration Establishing and maintaining key contacts with HA and regulatory organizations Evaluating opportunities for product development (acceptability of documentation, forecast of product status, peculiarities of registration procedure, etc) Assistance the GRA Head and Local RA managers in maintenance of regulatory activity in CIS countries (Legal Entities consolidation, process coordination) Pharmacovigilalence activity: keeping contact with National Authorities, cooperation Training of the company employees on pharmacovigilance Conditions: Western pharmaceutical company Full social package Salary is discussedUpper-intermediate English is a must

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