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

Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs Our client, a global pharma company, are currently recruiting for a Senior Manager Regulatory Affairs to join their team on a permanent basis. Prior experience of people management is essential for this role. This role offers hybrid working. Responsibilities Recruit, develop, and retain a diverse and highly capable workforce Ensure robust individual training plans and timely completion of required training for direct reports Support and enable talent identification and career development that reflects an ...

Location: Cork,
Senior Manager Regulatory Affairs 		Cork Not Disclosed

Senior Reguatory Specialist

Role: Senior Regulatory Specialist Location: Dangan, Galway Benefits: Competitive salary, Bonus up to 10%, Healthcare contribution, stock options and a flexible office and home working environment. Company: Founded in 2018 My client are a growing business with an exciting technology developing innovative catheter-based technology to remove clots from the brain following Acute Ischemic Stroke. The technology is designed to provide superior clinical outcomes in shorter procedural times, resulting in safe, cost-effective therapy. ...

Location: Galway City,
Senior Reguatory Specialist 		Galway City 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.