Are you a Senior Regulatory Affairs Officer who wants to work on the busy regulatory affairs team of a Global Generics Pharmaceutical company? This company was established over 150 years ago and is now the leading distributor of generic products in the Southern Hemisphere. They have a massive product portfolio and a global presence, with operations in 50 countries and supplying medicines to more than 150 countries. This role is based in a virtual manufacturing site in an accessible location in Dublin.
Day to Day:
As Senior Regulatory Affairs Officer, you will:
- Review of all assigned regulatory submissions/MAAs for accuracy, completeness and compliance with EU regulations and relevant guidelines; ensure that all additional specific country national requirements are met
- Identify and then obtain any deficient information in order to complete the compilation within the allocated time frame.
- Build departmental awareness of local regulatory requirements in global markets.
- Prepare the "master documentation" (containing all crucial correspondence and dossier up-dates required during registration procedure) to support all future post registration amendments and variations.
- BSc in a Life Science or Pharmacy
- 3-4 years' experience in a regulatory affairs environment
- Detailed knowledge of EU current registration requirements for dossier preparation and procedure running.
Working as Senior Regulatory Affairs Officer you will be based in a new and modern office in West Dublin. You will be welcomed in to a friendly and inclusive work environment with a smart casual dress code. You will join a busy team working at a fast pace on an extensive portfolio of products. The team has grown massively over the last 5 years and has plans for further expansion. You will gain a wealth of knowledge and experience working with a large and supportive team in a company that has a clear progression path.
For immediate consideration, please apply below with an up to date CV. Not sure yet? No CV ready? Give me a call for more information.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales