Beschreibung
Beschreibung / Aufgaben:- 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. The 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)
Skills / Profil:
- 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 eCTDs
- Good communication skills
- Good command of English in speaking and writing, knowledge of German is very welcome and useful.
- Team player
- Ability to work independently, solution-focused state of mind
- Reliable personality with the ability to prioritize and handle various projects at the same time.