Shirin Khorrami

Biography

  Regulatory Affairs Publishing Coordinator at GSK Management and execution of timely publishing and distribution process for regulatory submissions (such as the initial submission file to obtain the Marketing Authorization Approval for Europe or international markets, dossiers for the WHO, complex variations, renewal files) to regulatory agencies. Maintenance and continuously development of a high level of technical expertise of the submission tools and EU and international legislation in this context. Contribution in the establishment of a performance dialog in terms of capacity management in capacity cross-business meeting for publishing activities. Development and maintenance of Regulatory Affairs department operational databases to provide up-to-date reliable information systems within the department. Contribution in the archiving of regulatory dossiers (electronic and paper forms) for Regulatory Affairs Department.

Research Interest

Regulatory Affairs department operational databases regulatory dossiers