компания "manpowergroup" manpowergroup russia & cis and our client, american pharmaceutical company, are looking for a strong candidate with communication and interpersonal skills, team-oriented, self-motivated, multi-task management and problem-solving abilities for regulatory affairs specialist обязанности: preparing regulatory registration, notification, and pre-market submission requirements, including the necessary regulatory documents. providing regulatory support for product changes/modifications, labeling, and promotional material review and approval. supporting strategic planning and product development efforts. managing product lifecycle from pre-market to post-marking phase, including reviewing and approving promotional material in compliance with corporate and government requirements. providing regulatory guidance to local business partners and liaising with ra teams. ensures compliance with regulatory agency regulations and interpretations. prepares responses to regulatory agencieschr(39) questions and other correspondence. organizes and maintains reporting schedules for new drug application and investigational new drug applications. prepares necessary outputs, including outlines, summaries, status reports, memos, graphs, charts, tables, and slides. provides solutions to a variety of problems of moderate scope or complexity. conducts searches of existing files for requested information. maintains and archives all regulatory documentation. требования: minimum of a b.a. /b.s. within a technical related discipline is required minimum of 2-5 years of experience in regulatory affairs or master’s degree with equivalent experience. ability to work both independently and in a team environment. ability to problem solve, recognize and find solutions for gaps in processes. english good level written and spoken условия: manpower fix-term contract (outsorce) for 1 year, contract extension is possible; competitive salary; working time: 5/2 since 9.00 a.m. to 18.00 p.m. full time. minimum 3 days a week at the office with the option of up to 2 days remote work. needs to be discussed and agreed with local ra management. territory: business center krylatskiy hills.
Адрес
Москва