Regulatory Affairs Maintenance - EU

Description

Role: Regulatory Affairs Maintenance - full lifecycle Role - EU

Up to £60,000 + 15% bonus, relocation package if needed + excellent benefits package

Location:UK- South East, commutable from centralLondon,Cambridge,Essex,

Home working: Up to 1-2 days maximum per week

This opportunity is with a Global top 10 Pharma. This is a new team in the department focusing on Oncology and Pain products.

In order to apply with must have had expereicne with:

The candidate should have between a minimum of 3-4 years working experience with EU pharmaceutical environment, e.g. MRP/CPs/national procedures and has completed successfully the following regulatory activities

MRP Variations (type I, Ib and II)

MRP Renewal

PSUR exposure

MAA or extension application (will be a plus)

It is important that in their previous roles they got experience in interacting directly with National competent authorities and/or EMA

It is also important that their responsibilities were not only completing application forms but also at providing Project team with regulatory strategy. This means they know to classify a variation and also provide team with regulatory guidance (timelines, implication of the change for the international markets)

Lastly, Candidates should be able to contribute to the submission document creation and review.

If you would like to find out more information please send me an updated copy of your C.V to n.hopkins(a)realstaffing.com

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