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

Regulatory Affairs Specialist

Regulatory Affairs Specialist required for a Limerick based Medical Device facility. We’re currently recruiting for an exciting opportunity with a Medical Device facility based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Essential Duties and Responsibilities may include, but are not limited to, the following: Inputs to development of regulatory strategies and provides guidance and expertise. Compiles and communicates regulatory requirements...

Location: Limerick,
Regulatory Affairs Specialist 		Limerick Not Disclosed

Regulatory Affairs Specialist

Regulatory Affairs Specialist required for a Limerick based Medical Device facility. We’re currently recruiting for an exciting opportunity with a Medical Device facility based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Essential Duties and Responsibilities may include, but are not limited to, the following: Inputs to development of regulatory strategies and provides guidance and expertise. Compiles and communicates regulatory requirements %2...

Location: Limerick,
Regulatory Affairs Specialist 		Limerick Not Disclosed
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Regulatory Affairs Specialist Career Profile

Regulatory Affairs Specialist

There are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.

Salary Scale:


  • Regulatory Affairs Assistant - €25,000 - €28,000
  • Regulatory Affairs Officer - €32,000 - €39,000
  • Regulatory Affairs Specialist - €40,000 - €55,000
  • Regulatory Affairs Manager - €60,000 - €80,000
  • Regulatory Affairs Director - €85,000 +

Role 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 pharmaceutical 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.

Industry 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.