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Менеджер з реєстрації лікарських засобів

1 месяц назад
22 августа 2023

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.


  • 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


  • 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.