Вакансія CMC Regulatory Affairs Specialist

Infopulse Ukraine is looking for talented professionals to join our project and to work as a CMC Regulatory Affairs Specialist in our Kyiv office.

Qualifications

• University degree in Pharmacy/Medicine
• 2-3 years experience as Regulatory Affairs manager/specialist
• Experience in and knowledge of other relevant areas (such as research, quality control, manufacturing or quality assurance) within the pharmaceutical industry will be a plus
• Very good command of English (Common European Framework B1)
• Comprehensive knowledge of the Ukrainian Regulations of medicines

Areas of Responsibility

• Handling of regulatory submissions (new registration, renewal, variations): compiling dossiers in accordance with the company’s and local legislation requirements, performing all necessary regulatory activities for the assigned products:ordering necessary documents for submissions, analyzing dossiers, preparing methods of quality control, instructions for medical use, etc.
• Planning of regulatory procedures in cooperation with other departments
• Planning and managing of medical products/food supplements registration process according to the company’s business plan
• Developing Normative documents, Patient Information Leaflets, and Product Packaging Artworks
• Tracking regulatory databases, maintaining high level of compliance and ensuring that reporting accuracy is maintained.