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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.