Regulatory Affairs Officer

Pe Global

Waterford

Key Responsibilities include but are not limited to: Working within a team to provide full support to all registration activities and regulatory submissions for new product developments across a diverse range of territories. Work closely with the team to facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies. Maintain information on worldwide regulatory requirements and the status of product registrations. Liaise with all departments and project teams to co-ordinate timely applications for regulatory approvals. To be aware of progress and developments of worldwide regulatory requirements. Interaction with FDA and EMA on filing strategy and dossier content during the on-going development of a portfolio of new drugs. Ensure up to date files are maintained for all licensed products manufactured and/or released. Review of relevant reports to ensure compliance with licence details and relevant guidelines and directives. Requirements: Adegreein Chemistry or Pharmacy (or a related discipline. 1 -2 year Regulatory experience covering medical devices is desirable. Commanding knowledge of worldwide regulatory procedures, especially for medical devices. Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales. Possess computer competency in Microsoft office software, data collection and general analysis tools. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

1969 days ago