Responsible for the Life Cycle Management of assigned products according to EU regulations and other country regulations where the products are registered • Ensure compliance of products with Authority Regulations, decisions & decrees and with Quality system requirements whichever is stringent • Preparation, Compilation and submission of all the maintenance activities (Renewal & variations) based on company plans and in compliance with Regulatory Authority guidelines; address queries from the regulatory authorities and obtain the approvals • Coordinate administrative tasks such as ordering translations, legalization, CPP to facilitate submissions • Change control evaluation • Responsible for keeping Orion Internal Regulatory systems up to date and accurate • Keep the regulatory archive complete and ensure that all current licenses and labelling are up-to-date • Coordination with Internal and External stakeholders for effective implementation of the change • Follow and comply with all the defined internal policies and procedures of working.
