Regulatory Affairs Specialist

Updated: March 06, 2024 05:48 AM GMT

Full time Job in Kyiv, Kyiv city

50056703 - Senior Specialist Reg Drug Proj Del

Kiev, Ukraine

Our expectations for candidates:
• Higher education in Pharmacy, Medicine or Biotechnology;
• Experience in the field of drug registration at least 3 years;
• Knowledge of local regulatory standards, requirements and legislation practices;
• English at the Intermediate level;
• Good command of: Word, Excel, PowerPoint, Outlook;
• Excellent planning and organizational skills,
• A high level of result orientation and time management;
• High level of communication and business negotiation skills;
• Proven ability in important information.

Responsibilities:
• Preparation of registration of dossier materials (synthetic and biological medicinal products) in accordance with the requirements of Ukrainian legislation and company procedures (including, but not limited to: methods of quality control of the medicinal product, instructions for medical use of the medicinal product, labeling text of the medicinal product); proofreading and correcting the translation of the necessary documentation... More Detail