Regulatory Affairs Manager (m/w/d) – Freelance – on hold

  • Position zu besetzen ab 1. August 2019
  • Permanent-ID OCR-FL-747
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Aufgaben:
· Acting as product responsible for Biosimilars for marketing authorisation applications within the EEA and Switzerland
· Performance of new applications in the EEA and Switzerland
· 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 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 optimisation of internal processes
· Responsibility for deadline monitoring of regulatory projects
· Data maintenance in the Corporate Regulatory Marketing Authorisation Database system
· Creation of registration dossiers for new product applications using electronic systems

Anforderungen:
• Experience in Regulatory Affairs in the EEA is a must, especially new applications via DCPExperience 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

Projektumfang: 4-5 Tage/Woche (remote nur einzelne Tage nach Absprache)

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