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Search Results for Regulatory Affairs Executive
Job Title. Location Salary Actions

Regulatory Affairs Manager

Regulatory Affairs Manager Our client requires a Regulatory Affairs Manager to joint their team on a permanent basis. The ideal candidate will have excellent

Location: Kerry,
Regulatory Affairs Manager
Kerry Not Disclosed

Regulatory Affairs Specialist Remote Working and Part Time Opportunity

Regulatory Affairs Specialist Remote Working and Part Time Opportunity Our client are currently recruiting for a Regulatory Affairs Specialist to join their D

Location: Dublin,
Regulatory Affairs Specialist Remote Working and Part Time Opportunity
Dublin Not Disclosed

Senior Regulatory Compliance Officer

Senior Regulatory Compliance Officer Our client, a global healthcare organisation, requires a Senior Regulatory Compliance Officer to join their team for fixed term contract, the duration of which is 6 months. The successful candidate will manage, review registration information and provide this information to relevant departments, and to ensure regulatory compliance for all products released. Responsibilities • Manage the review of registration information supplied by various regional registration centres and provide the information as appropriate to the relevant...

Location: Dublin,
Senior Regulatory Compliance Officer
Dublin Not Disclosed
Other Regulatory Affairs Jobs
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Senior Regulatory Affairs Officer Dublin West Not Disclosed
Research and Development Compliance Specialist Galway Not Disclosed
Senior Director, Regulatory Affairs Dublin Not Disclosed
CMC Regulatory Affairs Director Dublin Not Disclosed
Senior Director, Regulatory Affairs Dublin Not Disclosed
Senior Director, Regulatory Affairs Dublin Not Disclosed
Senior Regulatory Affairs Officer Dublin West Not Disclosed

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)


  • 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.
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