Description
Main Responsibilities: * Maintain marketing authorisations for a specified portfolio: Submit Variations; Safety and CMC etc * Update and develop labeling texts; SmPC, PIL and packaging artwork texts * Liaise with local commercial teams including; Product development, Product Launches and Promotional Material and Prescribing Information * Liaise with local commercial teams and communicate significant regulatory issues/developments to commercial and the potential impact on the company business* Product development * Product Launches * Liaise with Global Regulatory Affairs on regulatory issues. * Liaise with external regulatory authorities - (where applicable to the product portfolio). * Develop and maintain regulatory Standard Operating Procedures as required. * Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements. * Gain marketing authorisations for pharmaceutical products in Ireland and Europe (as applicable)Required Experience: * 3 years of Regulatory experience * Strong registrations and Post Marketing experience
* MRP, DCP and CP submissions experience* Some Pharmacovigilance experience * Life Sciences Degree or equivalent experience