Specialist, Regulatory Affairs FDF

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 Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global RA environment. Cross functional alignment internally and externally in relation to regulatory updates, variations packages, and regulatory procedures. Contribute to write and review SOP’s related to department. Report all regulatory data related to activities to ensure RA workplan and MA databases are up to date Support in MDS compliance and creation Escalating to senior RA staff in case of complex regulatory issues or risks including implications. Key Shared Accountabilities Ensure support to RA-FDF team and other disciplines within FDF and Centrient in order to meet objectives Execute on performance management and act accordingly Compliance for FDF