Обязанности:
Regulatory Affairs Manager is to create opportunities for the Company's business in Russia by registering new products and maintaining the registration of existing products, as well as ensuring compliance of local registration documents of the Company's products with the established requirements of the legislation of the Russian Federation Responsibilities Initial registrations, renewals and variations for medical products (Rx/OTC), medical devices (3 class of risk) and cosmetics in Russia Develop RA strategy Develop regulatory platform and environment, including service providers Support EAEU GMP inspections & QMS audit Ensure compliance of approved ND/PIL/Artworks with marketed products Submit the registration dossier to the relevant authorized bodies, track the stages of registration procedures, prepare responses to deficiency letters/requests from authorized bodies, receive registration documents Prepare local dossiers in accordance with corporate requirements and appropriate legislation Identify registration strategies and types of registration procedures for medical products, medical devices and cosmetics Interact with authorized local regulatory and expert bodies in the field of registration and declaration Monitor changes in the field of registration of medicines, medical devices and cosmetics and promptly implement all the necessary changes in the Company SOP updating and revision Leading cross-functional projects Support for related departments to keep promotional, scientific and educational materials in compliance with Corporate and regulatory requirements Close collaboration with Global Regulatory team Lead cross-finctional and multy-cultural teams, ensure the effective teamwork Important for us University degree in Medical/ Pharmacy / Chemistry 5+ years of experience in Regulatory sphere Proven leadership and ability to drive result Proven experience of successful registrations Proven experience of getting EAEU Marketing Authorizations for medical products Deep understanding of Regulatory legislation both local and EAEU Proficient business English written and spoken is a must We offer Competitive salary and bonus system Health and life insurance Meal allowance and corporate mobile coverage Corporate reward and recognition program Unlimited opportunities for professional self-realizationПохожие вакансии