Teva Regulatory Affairs Senior Professional 

Croatia, Zagreb 

672161014

• Support EURA strategists in the preparation and submission of Clinical Trial Applications (CTAs) and CTA maintenance activities (e.g. Substantial Modifications), including interactions with external stakeholders (e.g. Contract Research Organizations) and redaction of regulatory documentation related to personal and commercially confidential information in collaboration with EURA strategists
• Support EURA strategists in the preparation and submission of regulatory post-approval filings via the centralized, decentralized and mutual recognition procedures, including labelling activities
• Support EURA strategists in liaising with Health Authorities where appropriate
• Understand and accurately follow guidance on all EMA/EC regulations, guidelines, procedures and policies
• Support of team leaders with departmental reporting and metrics, including maintenance of databases, workplan, and report compilation
• Provide general filing and administrative support for EURA strategists, such as uploading correspondence with Health Authorities to the eDMS, collecting and checking specific administrative documents for Module 1 of the registration dossier, proof reading of mock-ups for the existing products portfolio against the approved labelling text, and ensuring compliance at all times
• Support EURA strategists in maintaining the electronic documentation management system (eDMS) and regulatory information systems
• Work closely with the line manager to ensure completion of tasks within agreed timelines
• Identify and escalate areas of administrative process improvement
• Actively participate in the establishment, review and improvement of working procedures relevant for GRAIM (Europe)
• Provide ad hoc support to requests from GRAIM team members and other functions
• Support special tasks and/or specific topics on behalf of the EURA team and share knowledge
• Occasional travel might be required

• Minimum bachelor's degree in a scientific or healthcare discipline, or an equivalent combination of education and related experience; Pharm.D, M.S., Ph.D., or equivalent, or sufficient related experience would be ideal
• Experience in the pharmaceutical industry, ideally in Regulatory Affairs
• Practical experience with European regulatory activities/submission procedures would be preferable
• Experience and knowledge of the eCTD would be ideal; a basic understanding of European regulatory requirements and guidelines would be highly preferable
• Proficiency in Microsoft Word, Excel, PowerPoint, SharePoint, Outlook, and Adobe Acrobat; use of databases and eDMSs would be preferred
• Excellent verbal and written communication in English, ability to work under pressure and to tight timelines, effective time and organization management, and initiative
• Creativity, team work, problem solving skills, flexibility, planning and organization skills, attention to details
• Ethical scientific and intellectual integrity

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