Description
Regulatory Affairs ManagerMy client, an industry leader in the medical and pharmaceutical field is looking for a Regulatory Affairs Manager. The company distributes and sells their products in over 80 countries. The regulatory affairs manager will be working with the company's 700 products from their manufacturing site in Galway.
What you will be doing:
*Responsible for supervising and managing maintenance of products
*Responsible for supervising and managing dossier preparation and submissions process
*Manage the obtaining and maintenance of product licenses and marketing authorizations
*Responsible for the communication of regulatory information within the team
*Responsible for overseeing artwork approval and manage information transfer from the regulatory department to new product development dept, quality assurance/control department and production department
*Working closely with the QPPVs to oversee the approval of regulatory invoices
*Maintaining and setting department KPIs
*Preparing, maintaining and managing department SOPs
What you will need:
*A scientific/life science qualification and background
*5 years experience in regulatory affairs in the pharmaceutical sector
*Experience with DCP/MRP and product applications
*Computer literacy (ECDL) and strong IT skills
*Excellent communication skills
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
To find out more about Real please visit www.realstaffing.com