Teva Senior Regulatory Affairs Professional 

Croatia, Zagreb 

625849512

• Collection and preparation of documents intended for submission of CMC variation packages
• Evaluation of changes and support for their implementation in drug documentation for EU, US market, as well as monitoring the status of requests and agreed activities
• Participation in meetings for projects within responsibility and informing other organizational units about the content of the registration file
• Work with regulatory team and other functions to create solutions and implement agreed mitigation plans
• Provide regulatory input throughout the product life cycle of responsible product lines and understand or raise regulatory obstacles to Head of regulatory Function
• Preparation of responses to authorities’ requests within regulated timeframe
• Update status through electronic systems, database and relevant forums

• University degree (Pharmacist/Biologist/Chemist)
• 2-3 years of experience in regulatory affairs in CMC, quality assurance and control, drug development or analytics will be an advantage
• Experience of working with Multi-national companies in Pharmaceuticals
• Knowledge in regulation, requirements and guidelines
• Proficiency in written and spoken English languages
• Ability to work in dynamic environment and multi-tasking
• Ability to work both individually and in the team, to cooperate on cross-country level and with different business units
• Experience in global environment is an advantage
• Experience with sterile products is highly desirable
• Knowledge with electronic systems and databases

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