Ваш надежный помощник
We are looking for a reliable team-player of the Regulatory Affairs Department and the company office in general. The work with us will provide a good experience in the international cooperation, deep inclusion into the European pharmaceutical standards and a professional working atmosphere.
Требования:Master's degree in Medicine/Pharmacy/Chemical technology and engineering/Biotechnology and biological engineering/Chemical/Biology. A professional experience of at least 2 years in regulatory affairs is a must. Knowledge of the international guidelines and national legislation related to RA and PV. English – not lower, than Upper Intermediate. The candidate can count on the support of colleagues and training, if necessary. The reference list on the previous places of work is desirable.Driving license is appreciated.
Обязанности:Carrying out of regulatory procedures in accordance with the local requirements. Assessment of registration dossiers, renewal dossiers, variations according to the current requirements. Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with the local normative regulations. Preparation of application forms, registration forms, drafts of the instruction for medical use, QCM, statements and variation dossiers. Supporting the local logistic system. Conducting the procedure for GMP confirmation in Ukraine. Corporate coordination between HQ and the company's representative.
Условия:Full time job Competitive salary Mobile phone Company car
Подписаться на расcылку новых вакансий: "Специалист Отдела регистрации лекарственных средств в Чабанах"