Обязанности:
Responsibilities: A full cycle preparation of dossiers (modules 1-5) for a new registration/ bringing in line with the EAEU requirements, dossiers for EAEU variation submissions. Preparation of Normative documents, instructions for medical use, Summary of Product Characteristics, packaging layouts for new registration as well as amendments to the mentioned documents. Interaction with MoH experts (communication by e-mail, over calls to a certain regulatory procedure). Fulfilment of direct and indirect regulatory activities to ensure maintenance of the regulatory status of the registered medicinal products and their smooth commercialization. Ensure translation of documents necessary for dossiers submission of to regulatory authorities. Provision of regular information to the management about the stages of the ongoing regulatory procedures and any changes required. Tracking the correctness of the information entered in the State Register of Medicines on the national and EAEU level. Execution of documents for state duties payment. Fulfilment of activities related with samples/RS import for regulatory purpose (preparation of documents for import permission submission to the Regulatory Authorities, import permission obtaining, interaction with the customs clearance vendors, preparation and submission to the labs) Coordination with the Head office (Regulatory and other functional teams) to ensure fulfillment of the above-mentioned activities. Requirements: At least 3 years in a similar position: - dealing with medicinal products - full cycle dossiers handling/preparation (EAEU modules 1-5) - working experience at foreign companies – at least 1.5 years Knowledge of the relevant regulatory national and EAEU legislation Good presentation skills in MS PowerPoint English – upper-intermediate, good skills in written and oral communication Benefits: Competitive salary; Annual bonus; Medical insurance; Meal allowance; Mobile allowance; Hybrid work schedule.Похожие вакансии
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