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