• Acting as product responsible for marketing authorization applications within non-European countries (CIS region, e.g. Russia, Ukraine, Kazakhstan, ASEAN, SEE region e.g. Serbia, Bosnia, etc. and MENA region)
• 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.
• STADA’s 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 is a must
• Experience in working with Document Management Systems as well as Publishing Systems,
• experience in creating and handling of eCTDsGood communication skills
• Good command of English in speaking and writing, knowledge of German is very welcome and useful.
• Team playerAbility to work independently, solution-focused state of mind
• Reliable personality with the ability to prioritize and handle various projects at the same time.
Location: Bad Vilbel
Project start: 07.01.2020
Duration: 3 months
Availability: 5 days / week