Regulatory Affairs Manager (Specialist) / Менеджер по регистрации (специалист)

Job 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 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 fulfilment of the above-mentioned activities.

Requirements:

1. Education: Higher pharmaceutical, chemical biological or medical education.

2. Experience: 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;
• Experience in EAEU GMP inspections, CT (BE) studies coordination, knowledge in PV and QA requirements will be considered as a plus.

3. Personal traits and skills:

• Communicable, proactive, team- and result-oriented;
• Good presentation skills in MS PowerPoint;
• English – upper-intermediate, good skills in written and oral communication.

Terms and conditions:

• Оформление в соответствии с ТК РФ.
• График работы 5/2, 9:00 - 18:00, ст.м. Водный стадион.
• ДМС, соцпакет.
• ЗП по результатам собеседования.