Today KUSUM is in the TOP-10 leaders of the Ukrainian pharmaceutical market. For 25 years of our activity, we have done our best to constantly offer only high quality, effective and safe medicinal products.
KUSUM is a special microclimate. We provide each employee with health insurance, a corporate gym, and a medical room within the office; our chefs cook fresh lunches every day. We also offer many other things to take care of the comfort and health of our employees.
Currently, we are looking for a colleague in the Department of registration and standardization of medicinal products – development of registration dossiers (English language).
Type of employment: on a permanent basis, 5 days a week.
Schedule: presence in the office is mandatory.
For this position, we would appreciate:
- higher pharmaceutical/chemical education;
- knowledge of the legal requirements on the medicines registration in Ukraine, along with international requirements;
- knowledge of modern guidelines on the quality, safety, and efficacy of medicinal products, including:
- pharmaceutical development;
- assessment of in vivo / in vitro equivalence;
- quality of active ingredients, excipients, and packaging;
- specifications of medicinal products, control methods, validation of methods;
- validation of technological processes;
- stability study of substances and drugs;
- experience in evaluating the compliance of documentation regarding the quality, safety, and efficacy of medicinal products to the requirements of Ukrainian legislation and international guidelines;
- ability to work with technical and scientific pharmaceutical documentation;
- knowledge of the English – Advanced.
- development/examination of dossiers for registration of medicinal products in STD format (Module 1, 2, 3);
- submission of dossiers and samples of the finished medicinal product to regulatory authorities, receiving requests and approved documents;
- interaction with employees of state expert organizations that carry out examination of documents and quality for the purpose of registration of drugs;
- control and ensuring the completion of registration processes in regulatory authorities. Preparation of responses to requests from regulatory authorities;
- management of document circulation from the dossier;
- interaction with departments of pharmaceutical development, quality assurance, quality control, as well as other departments on regulatory issues.
- official employment from the first day according to the Labor Code of Ukraine;
- timely salary and planned salary increase;
- corporate events;
- care of Your health and medical insurance;
- work schedule: full time, Mon.–Fri. 09.00–18.00. Remote collaboration is not considered!
- our new and modern office is located on the Left Bank in the DVRZ area (the nearest station – Chernihivska).
To start working at KUSUM, please send Your CV indicating Your financial expectations.