• Acting as product responsible for marketing authorization applications within non-European countries
• Performance of new applications in non-European countries.
• Main responsibility is on preparation, submission, management and finalization of Decentralized Procedures.
• New applications will partly be run internally and partly be monitored when run by external partners.
• A special focus is on compilation of Module 1.
• Preparation, checking, revising, finishing and maintenance of all regulatory documents
• Coordination of project teams with Regulatory Affairs employees as well as with other internal and external suppliers, strong interface position.
• Participation in project meetings representing Regulatory Affairs.
• Main contact person for NON-European Regulatory Authorities during ongoing new application procedures
• Direct responsibility for planning and implementation of regulatory projects and for decision making
• Project management and –reporting, as well as escalation management, if required.
• Constant participation in the optimization of internal processes
• Responsibility for deadline monitoring of regulatory projects
• Data maintenance in the Corporate Regulatory Marketing Authorization Database system
• Creation of registration dossiers for new product applications using electronic systems (DMS: FirstDoc/Publishing: DocuBridge)
• Experience in Regulatory Affairs in non-european countries
• Experience in working with Document Management Systems as well as Publishing Systems, experience in creating and handling of eCTDs
• Good communication skills; Good command of English in speaking and writing; knowledge of German is very welcome and useful.
Location: Bad Vilbel
Project start: latest at the End of September 2019
Duration: 3 month
Availability: 4-5 days/week