Regulatory Affairs Specialist

Pe Global

Waterford

Our client based in Waterford is currently looking to recruit a Regulatory Affairs Specialist. This role will support activities associated with the registration of company products in Worldwide markets, as well as Regulatory compliance liaison with QA for registered products. The Role: Licence maintenance support to customers, Regulatory agents and internal departments. Regulatory Compliance liaison with QA. Support licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East. Dossier preparation for submission. Strategic planning of regulatory activities. Support activities in the areas of Bioequivalence and Clinical safety and efficacy study management. Requirements. 1-2 years + regulatory affairs experience desirable working in the pharmaceutical industry. Degree preferably in Chemistry, Pharmacy or Pharmacology. Excellent knowledge of regulations and sources of regulatory information. Excellent knowledge of company procedures, policy and standards. Thorough knowledge of GMP and current FDA & EMEA regulations. Excellent planning and organisational skills. If you are interested in this role please email CV to aoife.lomasney@peglobal.net or contact Aoife Lomasney on 0214297900. 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.

1962 days ago