Regulatory Affairs Manager( ANCOR )

19 Октября

Партнерские Вакансии

Компания "ANCOR"

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.