Regulatory Affairs Specialist Career Profile

Regulatory Affairs Specialist

• 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 +

• 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.

• 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.