Требуется Regulatory affairs specialist (код muoz12123)
Заработная плата: по договоренности.
Должностные обязанности- Ensures the compliance with requirements of the authorization applications to obtain registration in time; - Support of registration process of products: elaboration and harmonization of normative documentation for the products, preparation of chemical part of the dossier in accordance with National rules; - Submission of documents to MoH for registration and re-registration of products; - Cooperation with production and research sub-units; - Responsibility for control pharmaceutical laboratory examination - Elaboration and harmonization of variation for normative documentation and pack insert for products; - Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations. - Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples and other items are provided to relevant agencies as needed. - Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new normative documents related to registration of medicines. - Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country. - Provide information about the various tests, trials that are required to generate data for submission of a Dossier.
Требования к квалификацииWorking in the pharmaceutical business in regulatory-medical department for more than 2 years. Availability of knowledge of legislation and procedures of the Russian Federation in the Regulatory Affairs field. - Expert knowledge in Chemistry, Pharmacology, pharmaceutical technology and overlapping areas. - Skills of interpersonal business communication, correspondence, organization and negotiation. - Advanced PC user. Computer skills and knowledge: MS Office, Adobe Acrobat - English language upper intermediate.
Условия работы и компенсацииInternational Pharmaceutical Company
Опубликована 28.09.2014. Актуальна до 14.10.2014.
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