Regulatory Affairs Strategy Consultant

Ideally the candidate will have the following experience as the role will heavily involve:

- Ability to lead cross matrix teams across regulatory/medical/safety, etc to an end goal (i.e. regulatory filing)
- Knowledge of EU regulations and experience in EU procedures, specifically MRP/DCP procedures
- Experience in communicating with health authorities
- Proven record of EU authority submissions (i.e. variations, query responses, agency negotiation)
- 5+ of direct regulatory experience, experience as Regulatory Lead not required, but advantageous.
- Detailed knowledge and expertise in EU regulations.
- Direct experience and proven track record with EU MRP/DCP submissions, queries responses and approvals.
- Direct experience and demonstrated track record in communicating/negotiating with Major Regulatory Authority(ies)
- Experience working in leading highly matrixed, global and multi-site environment/teams
- Track record of supporting various products in different therapeutic areas and at different stages of products life cycle.

If this role could be of interest to you and you would like to discuss it further then please contact Peter Duvall on 02077587322To find out more about Real please visit www.realstaffing.com