Regulatory Affairs Manager, Russia& CIS/Менеджер по регуляторным вопросам, Россия и СНГ

International company is looking for Regulatory Affairs Manager, Russia& CIS Key responsibilities: Gather a thorough knowledge of the registration files and all related company product documentation. Keep up-to-date on Company products; Coordinate handling of company core data sheet (CCDS) updates; Review and sign-off registration packages prior to submission; Gain Regulatory Authority approval for marketing authorizations for new products; Maintain all existing product marketing authorizations and gain Regulatory Authority approval of variations (amendments) to these authorizations as required; Manage any further information requests from local Regulatory Authority in a timely manner; Review Product Information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate, updated and approved by both Company and relevant Regulatory Authority in accordance with Company policies and local regulations; Create Product Normative Documents in accordance with company’s analytical guidelines and local regulatory requirements; ensure that all information is accurate, updated and approved by both Company and relevant Regulatory Authority; Provide appropriate amounts and list of samples, reference standards, reagents and equipment required for pre-submission and registration testing of drug products; Provide necessary support in local pre-submission laboratory testing; Perform regulatory review of promotional materials. Skills& knowledge: Education: University degree in Pharmacy, Medicine or Life Sciences; Comprehensive knowledge of Russian and EAEU Regulatory Affairs requirements; Strong knowledge of professional terminology (CMC, analytical, chemistry); Upper-Intermediate in English both verbal and written, efficient computer Skills; Good presentation skills; Sound judgment, strong communication and negotiating skills; Teamwork skills; Attentive to details, responsible and well-organized.