Regulatory Affairs Executive Career Profile

Regulatory Affairs Executive

• 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.
  

• 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.