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REGULATORY AFFAIRS SPECIALIST

 

Company:

CPL
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Job Reference Number

13429537

Client ID:

RI/JNABC2
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Posted On:

Jun 8 2009

Location:

DUBLIN WEST
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Job Type:

Contract

Salary:

NEGOTIABLE
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My client is a global leader in their field. They are seeking a senior Regulatory Affairs Consultant with circa 5 years RA experience.

The Role:

  • Responsible for the co-ordination of all project activities
  • Responsible for the development of site-specific project plans and the development of work processes / streams for the project execution
  • Reviews and interprets regulatory submission documentation in the context of plant technical information, SOPs and documentation
  • In consultation with the global project team and the local product regulatory specialists, develops regulatory submission strategies for international markets, and as appropriate participates in their execution.
  • Prepare, Review and submit submission ready Chemistry, Manufacturing and Controls (CMC) documents.
The individual:

  • Excellent communication skills
  • BSc or relevant qualification
  • 5 years minimum RA experience
  • TOPRA membership would be an advantage but is not essential
The position:
This is a project based role estimated to last until December 09. Contract could be extended further beyond that point.

For more information please contact Jenny Navan on 01 614 6072 or email for further details.

All applications will be treated in the strictest confidence.

www.cplscience.ie