Regulatory Affairs Officer
- Waterford, Republic of Ireland
- Regulatory Affairs
Are you a Regulatory Affairs Officer interested in joining a healthcare company that are passionate about the development, manufacture and supply of high-potency pharmaceutical products? The company based in Waterford use state-of-the-art facilities to develop and supply life-saving medicines all over the world. As Regulatory Affairs Officer you will support the registration of human, veterinary and generics products in worldwide markets including US, EU and Japan.
Day to Day:
As Regulatory Affairs Officer, you will be responsible for:
- 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 to all target markets, including liaison with R&D, QC, and Production as well as external experts where required.
- Licence maintenance support to customers, Regulatory agents and internal departments.
- Regulatory Compliance liaison with QA.
- B.Sc. in Chemistry, Pharmacy or Pharmacology but any Science related discipline considered
- 1-2+ year's pharmaceutical regulatory affairs experience
As Regulatory Affairs Officer, you will be working with a friendly and dynamic, mid-sized team. Based in Waterford the site describes itself as cosmopolitan, wired and wild. It is a fast-paced, busy environment, with plenty of progression opportunities. If you would like to be a part of a world-leading pharmaceutical company, who take an invested interest in your growth and progression, then this is the opportunity for you.
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