Description
Regulatory Affairs OfficerMy client, a global generic pharmaceutical company in Tipperary is looking for a Regulatory Affairs Officer to join the Regulatory Affairs team.
The regulatory affairs officer will be working directly with the regulatory affairs manager and will be the sole point of contact within the department in their absence. This is a varied position and the opportunity for the successful candidate to really develop a broad range of skills and gain experience across the whole regulatory affairs department.
Your tasks:
* Prepare and review regulatory submissions for Ireland, UK and Europe
* Provide technical expertise and project specific regulatory strategy
* Act as a liaison between internal departments and external customers to support company projects
* Develop a working relationship with clients, regulatory personnel in other companies, with the regulatory authorities and internal departments
* Ensure the highest level of compliance with relevant organizational and Regulatory Affairs SOPs
Your skills:
* Third level scientific qualification
* Two years experience in a similar role in the pharmaceutical industry
* Previous working knowledge of country requirements/regulatory affairs procedures
* Experience in CTD dossiers and post approval regulatory submissions
* Regulatory submission experience in marketing authorisation applications
* Knowledge of electronic submissions to regulatory agencies
* Expert knowledge of European and global regulatory guidelines
An excellent salary plus a very attractive benefits package is on offer. This is an urgent requirement so interviews will be immediate. If you are interested in this great opportunity please contact me Laura Watson on and click apply with an updated CV for immediate consideration.
To find out more about Real please visit www.realstaffing.com