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CEO Medical Device Start Up
Republic of Ireland
QA Specialist
Dublin West
Senior Chemist
Dublin North
R&D Engineer
Galway
Principal Scientist
Dublin South
Head of Quality
Dublin West
Snr QA Specialist
Dublin South
Hospital Sales Specialist
Republic of Ireland
Microscopy Product Specialist
Republic of Ireland
Snr Process Engineer
Dublin North
QA Manager
Dublin West
QA Manager Biologics
Dublin West
Technical Sales Engineer
Republic of Ireland
Qualified Person
Dublin West
Market Access Manager
Dublin City Centre
QA Manager
Meath
Program Manager
Westmeath
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Regulatory Affairs Executive Career Profile

Regulatory Affairs Executive

The role concerns the filing and regulatory maintenance of Biopharmaceutical drug products. Depending on the company and the market authorisations for various drugs, Reg Affairs professionals will be required to deal with the IMB (Irish Medicines Board), MHRA (Medicines and Healthcare products regulatory Authority - UK) and FDA (Food & Drug Administration - US)

Responsibilities


  • Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
  • Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for biopharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
  • Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
  • Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
  • Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
  • Maintenance of approvals, including the preparation of annual reports for US products.
  • Assess and review documentation to ensure compliance with product licences.
  • Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
  • Actively participate in project teams, as required.

Qualifications / Experience

  • Minimum of 3 years regulatory experience in the pharmaceutical industry.
  • Knowledge of the current regulatory requirements, particularly US and EU.
  • Experience in writing and submitting regulatory documentation.