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

компания "ancor" 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.