Обязанности:
Key responsibilities: Liaise with regulatory agencies and provide appropriate responses to requests from regulatory agencies Implement and comply with the requirements of the quality management system in the processes: self-inspection, deviation management, CAPA management Provide legal support for GMP inspection Ensure timely submission and approval of registration dossiers, registration confirmations and amendments to registration dossiers according to prescribed plans Participate in appropriate training to improve knowledge and professional skills Take charge of developing and updating written standards Requirements: Postgraduate or graduate in pharmacy/biology/chemistry with considerable experience in Regulatory Affairs with managerial responsibilities Additional education in management is beneficial Knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry Fluent written and speaking English Experience in people management; team-building and team-working skillsПохожие вакансии
Менеджер по регистрациии биологических препаратов / Drug regulatory affairs manager
Договорная
Москва
Р-Фарм