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

Senior Regulatory Affairs Specialist

Our client is a leading Pharmaceutical organisation based in the West of Ireland. The Senior Regulatory Affairs Specialist will be a member of the Research and Development, Regulatory Science group in a well-established team. The role will be very diverse – always something new to learn. Very interesting products -very dynamic. This role will give experience of dealing with health authorities worldwide & working on maintenance projects as well as new projects. It will also involve the person taking leadership on projects under supervisor’s guidance. Full traini...

Location: Galway,
Senior Regulatory Affairs Specialist 		Galway Not Disclosed

Regulatory Affairs Associate

Regulatory Affairs Associate Our client is looking for a regulatory affairs associate who will deal with the compliance and approval of products. This person will also be responsible for determining and supporting regulatory activities. Responsibilities • Use technical solutions for problem solving • Improve quality of projects • Use strong writing skills to clearly define and describe technical information • Analyse customer complaints • Identify trends and corrective actions • Review and assess of change control activities for po...

Location: Westmeath,
Regulatory Affairs Associate 		Westmeath Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Medical Device Inspector Dublin Not Disclosed
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Associate MDR & Vigilance Specialist Galway Not Disclosed
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Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Regulatory Affairs Manager Westmeath Not Disclosed
Regulatory Affairs Manager Westmeath Not Disclosed
Senior Associate Regulatory Affairs Dublin Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Senior Associate Regulatory Affairs Dublin Not Disclosed
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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.