Менеджер з реєстрації лікарських засобів

We, a representative of the European pharmaceutical company Medac GmbH, 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.

Условия работы:

• Full time job
• Competitive salary
• Mobile phone
• Company car

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.