Regulatory Affairs Manager

London  ‐ Onsite
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Keywords

Description

A global Pharma based in the South-East of England require a Regulatory Affairs Manager to join their Regulatory team.

This is an exciting opportunity to join a global Pharma with one of the largest product portfolios on the market on an initial 12 month contract as a Regulatory Affairs Manager in their European Regulatory Affairs team.

The successful candidate will;
  • Obtain, manage and maintain product Marketing Authorisations (MAA) and Clinical Trial Authorisations (CTA) in line with business goals and legal requirements
  • Conduct associated regulatory activities for the specified European markets
  • Contribute to implementation and leading of projects, and building of expertise within the Regulatory Department
  • Provide Regulatory advice and information to meet customer and cross-divisional colleague requests
  • Manage and submit Marketing Authorisation Applications (MAA) to national/MRP/DCP/CP
  • Manage and submit MA variation applications
  • Manage and submit MA renewal applications
  • Influence Regulatory Authorities
  • Manage Clinical Trial Approvals
  • Populate and maintain Regulatory Databases
  • Obtain Authority Approvals for supply of unlicensed medicines
  • Safeguard compliance and manage packaging and prescribing information component updates (artwork, SmPC, PIL, labelling components)
  • Implement MA divestments, cancellations and product discontinuations
  • Contribute to good Regulatory practice
  • Support Regulatory Affairs group development
  • Provide support to Third Party Licences


Essential experience:
  • Relevant life science or chemistry graduate to honours level or equivalent (Masters Degree, Postgraduate Diploma or PhD preferred)
  • Relevant professional qualifications highly desireable (MSc in Regulatory Affairs)
  • Previous hands on experience in Regulatory Affairs, particularly in European markets
  • Member of TOPRA preferred
  • Demonstrated computer literacy
  • Excellent written and verbal communication skills
  • Proven strength in analytical thinking


If you would like to hear more about this role please do not hesitate to contact Colm Tobin at Real Staffing on .
Start date
06/2014
Duration
12 Months
From
Real Staffing
Published at
11.06.2014
Project ID:
723975
Contract type
Freelance
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