Responsibility for insuring earliest possible registration of all new or in-line products, claims, formulations and/or strengths, along with price registration/re-registration, shelf-life changes according to adopted registration strategies (and company's high ethical standards policy).
Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.
Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.
Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new normative documents related to registration of medical devices.
Cultivating best possible relations with local regulatory bodies and opinion leaders and enhancing the Company's image in the medical community in general.
Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country.
Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.
Medical insurance for the employee and his children (100% coverage);
Medical insurance for a spouse (50% coverage);
Life insurance (accidents)
Employee assistance programs
At least 1 years of experience in Regulatory Affairs (medical devices, pharma)
English – written, spoken
Excelent knowledge of MS Office (Word, Excel)
Personality: team player, well organized, attentive to details, enthusiastic, quick learner
Ability to work with big amount of information
Полная занятость, полный рабочий день, у работодателя