Regulatory Affairs Manager

Job type:
on-site
Start:
01/2013
Duration:
6 months
From:
Real
Place:
Cambridge
Date:
12/11/2012
Country:
flag_no United Kingdom

Project description:
Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), the EU RL will:

- Ensure that the client acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products

- Ensure timely regulatory compliance with above approvals

- May provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)

In regards to the daily activities and responsibilities the Regulatory lead will be involved with:

- Health Authority Interactions

- Regulatory Strategy and Execution

- Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals

- Regulatory Drug development

- Plans and manages regulatory submissions

They are looking to set up interviews over the next week so if this role is of interest to you then please don't hesitate to contact Peter Duvall on

To find out more about Real please visit www.realstaffing.com