Regulatory Affairs Principle Manager

City of London  ‐ Onsite
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Keywords

Description

Regulatory Affairs Principle Manager & Senior Regulatory Officer Role - Global Branded Pharma
This is an excellent company who offer flexible working hours, excellent career development and a friendly working environment.
This Global Pharma have the best retention rate out of any clients we work with (8 out of the top 10 pharma + smaller companies also).

You will be part of a brand new growing departments that is being built in the UK in their European headquarters. This is a highly visible role working with the senior members of the board (Senior Regulatory Directors & VP of Regulatory Affairs)
Location: South East - UK

Report: You will report to the EU Regulatory Head of Therapeutic Area

Package: Excellent package - very competitive with a 15-20% & extensive benefits package including flexible working hours.

The Position
  • The function of European Regulatory Affairs, Branded Products is to obtain registration for all new and branded products inEuropeand to ensure that the registrations for existing marketed products are maintained.
  • The European Regulatory Affairs Group manages communication with and submissions to European Regulatory Authorities and helps speed up the transfer of the company's medicinal products from the laboratory to the market.
  • The primary function of a Principle Regulatory Manager, Regulatory Affairs Europe is to manage both centralised and decentralised filings of branded medicinal products.
  • A second key task is to ensure that regulatory obligations for marketing authorisations issued by these systems are met and to provide a point of contact for EMA or national competent authorities.


Key Skills:
  • The candidate should have working experience with MRP/national products and have completed successfully the following regulatory activities
  • MRP Variations (type I, Ib and II)
  • MRP Renewal
  • PSUR
  • MAA (will be a plus)
  • It is important that in their previous role they got experienced in interacting directly with National competent authorities.
  • Broad EU experience.
  • Lastly, Candidates should be able to contribute to the submission document creation and review.
  • You should have worked on products approved by centralised procedure and has proven working experience with EMA


Please feel free to give Natalie Hopkins a call to find out more information on or email n.hopkins(a)realstaffing.com.

REFERALS: WE OFFER A £200 JOHN LEWIS REFERAL FEE FOR ANY REGULATORY PRFESSIONALS TO INTRIDUCE TO US THAT WE PLACE.

To find out more about Real please visit www.realstaffing.com
Start date
06/2013
From
Real Staffing
Published at
15.05.2013
Project ID:
536473
Contract type
Permanent
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