• Working knowledge of all modules of dossier • Keep in touch with international legislation, guidelines and customer practices • Keep up to the date with a companys product range • Ensure that a companys products comply with the current regulations. • Coordinate, prepare and review all appropriate documents, for example, dossier and submit them to regulatory authorities within a specified time frame in conjugation with the organization • Prepare and review of SOPs related to RA. Review of BMR, MFR, change control and other relevant documents • Monitor the progress of all registration submission • Monitor work of subordinates
