Description
Senior Regulatory Affairs Specialist - Global Clinical Research Organisation - Up to £45,000Senior Regulatory Affairs Specialist - Global Clinical Research Organisation - Up to £45,000
We are currently working with a leading global CRO who provide full-service drug development services to many of the top 10 pharmaceutical companies.
Due to recent developments, they have taken on a number of high profile projects and are looking for an experienced Senior Regulatory Affairs Specialist to add to the team and provide specialist regulatory expertise. You will be responsible for the hands on work as well as having the opportunity to mentor less experienced staff. This role will be a highly visible role, which requires previous experience in a CRO environment. You will have definite future career prospects within the company and the role will be paying up to £45,000.
Key Skills/Experience
- Candidate must have previous experience working on clinical trials within the Pharmaceutical/CRO industry
- Bachelors degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Coordinate and manage regulatory & ethics committee submission and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
- Preparation of technical documentation, such as IMPD's and IB's
- Ability to comply with SOP's, ICH GCP and national regulations as applicable
- Good knowledge of ICH GCP and the EU Clinical Trials Directive/National regulations
The company offers the opportunity to work across a number of new and exciting projects and exposes you to work closely alongside some of the worlds top leading pharmaceutical companies.
If this is of interest to you and you would like to find out more information on this position or any other regulatory affairs positions, please contact Amanda Edwards on or please email a.edwards(a)realstaffing.com
To find out more about Real please visit www.realstaffing.com