Regulatory Affairs Specialist

Preparation of registration dossiers Monitoring of changes Interaction with government agencies Interaction with foreign partners and regulators Participation in the development of quality documentation

Requirements

Higher professional education (pharmaceutical, chemical, medical, biotechnological). Proficient in English (B2-C1 level) - fluent reading and drafting of regulatory documentation, conducting business correspondence. Knowledge of the regulatory and legal framework in the field of medicinal product circulation (FZ-61, EAEU requirements, ICH, GMP). Experience in forming registration dossiers for medicinal products, medical devices, dietary supplements, including veterinary drugs.

Higher education — specialist degree, master's degree; Experience: 1 year