Вакансія Junior CMC Regulatory Affairs Specialist

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

Qualifications

• University degree in Pharmacy/Medicine is strongly recommended, or Bachelor’s degree or similar one to pharmaceutical area, scientific disciplines life sciences, or other related fields
• Very good command of English (Common European Framework B1) is mandatory, other language(s) will be an advantage
• Detail-oriented, accurate and persistent working style
• Fast learning approach
• Good computer skills: PC administration, electronic data management systems (knowledge of eCTD tools will be a benefit), regulatory/portfolio databases, MS Office applications (MS Excel, Access, Project, etc), SharePoint

Areas of Responsibility

• Handling 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 regulatory procedures in cooperation with other departments
• Planning and managing 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.