Position Overview
Description
Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.
Key Individual Accountabilities
Collection of information and preparation of dossiers and variation packages as and when required. Compilation and update of the product dossiers in portfolio for global and for customers registrations (Both NP and LCM) under guidance from Portfolio Lead and RA managers Support in activities related to pharmacovigilance Support in evaluation of CMC data required to support dossiers and variation packages. Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures Creation and updating of product information texts Keepin...