Senior Regulatory Affairs Specialist

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Location: GalwayMin. Experience Required: 2-3 yrs

Job Type: Permanent Full-TimeReference: JO099944j

Salary: NegotiableDate Added: 08/07/2010

Role:

Regulatory Affairs Spec

My client is a leading pharmaceutical company based in the West of Ireland. They are seeking a Senior Regulatory Affairs Specialist to join their team.

Within this position you will be responsible for:

  • Maintaining regulatory filings including annual reports and supplements to the FDA
  • Prepare registration submissions in CTD format for FDA, EU and worldwide approval
  • Monitor the progress of registration submissions
  • Monitor adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls
  • Maintain approvals
 Ideally, you will have: 
  • a Life Sciences qualification
  • 3 years regulatory experience in the pharmaceutical industry
  • Knowledge of the current regulatory requirements in the US and EU

 For further information on this position or similar roles please contact me on 01 614 6072 or email Jenny.Navan@cpl.ie 

Tagwords: Regulatory Affairs, Reg Affairs, RA, Regulatory Specialist, Pharma, Pharmaceutical, Injectables, Biopharma

Contact Name: Jennifer Navan

Telephone: 01 614 6072

Fax:

Email: Jennifer.Navan@cpl.ie

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Keywords:

Regulatory Affairs |   Reg Affairs |   RA |   Regulatory Specialist |   Pharma |   Pharmaceutical |   Injectables |   Biopharma |