Description
Main responsibilities:* Responsible for managing the compilation and maintenance of global regulatory master submission files, to ensure they meet the global submission requirements.
* Provide support to local countries in preparation of national/MRP for MAAs, variations, line-extension and other post-marketing requirements.
* Provide local and regional guidance on preparation of regulatory submission material.
* Act as the regulatory responsible for project planning electronic submission activities.
* Knowledge of preparing MAAs or variations in NeeS or eCTD format an advantage
Person specification:
* Excellent attention to detail.
* Minimum 5 years experience within Regulatory Affairs essential.
* Excellent computer skills in using MS office and electronic systems in Regulatory Affairs
* Some knowledge of Medical Device applications an advantage but not essential
* Pharmaceutical/Scientific university degree (BSc or higher)
To find out more about Real please visit www.realstaffing.com