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 knowle...