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Regulatory Affairs Specialist Vienna Austria,  

Posted on : 27 March 2017

Project Description

We are looking for professional qualified and enthusiastic candidates to take up a full-time position of a Regulatory Affairs Specialist to be involved in regulatory process for clinical trials and provide administrative support to the company s Regulatory Affairs Department in our office in Vienna. REQUIREMENTS College or University Degree, Life science degree is a plus Prior experience in clinical research or medical/health industry Native German, excellent English (written and spoken) Proficient user of standard MS Office applications Attention to detail Good communication, organizational and time-management skills Demonstrated ability to multi-task and work effectively in a fast-paced environment RESPONSIBILITIES The scope of responsibilities will include: Communication line for clinical project teams and PSI support services on regulatory matters Preparation of draft project-specific regulatory/ethics dossiers Document management including preparation, maintenance and filing of regulatory documents, maintaining working files, tracking systems, calendars and schedules Quality control of miscellaneous outbound documents Providing miscellaneous secretarial support to the Regulatory Affairs staff Depending on the experience, the responsibilities may also include: Preparation of regulatory and ethics committee submission dossiers, including import and export licenses Tracking regulatory project documentation flow and progress reporting Tracking changes/amendments to legislative acts pertaining to clinical trials in Austria Contact person for ethics and regulatory authorities, clinical project teams, subcontractors, vendors and clients for all regulatory matters Review of investigational product release-enabling documents Developing and implementing corporate quality control tools and techniques pertaining to Regulatory Affairs Training of company employees in regulatory aspects of clinical trials Providing miscellaneous support to the Regulatory Affairs staff



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