Review and guide the team in preparing dossiers for Europe, Australia, New Zealand, and Canada (EANC) regions. - Review and guide the team in responding to queries from regulatory agencies and customers in the EANC region. - Liaise with R&D, manufacturing plants, clinical teams, and respective EANC offices/BD teams. - Support the lifecycle management of EANC registered products by achieving variation approvals. - Maintain departmental databases. - Regularly study regulatory guidelines and stay updated on Electronic eCTD (electronic Common Technical Document) requirements. - Maintain and submit GMP (Good Manufacturing Practice) applications.
