Regulatory Affairs Manager
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.