Regulatory Affairs Technician

Experience of at least 1-2 years in the field of Regulatory Affairs

Specific training in Regulatory Affairs

Main responsibilities :

• Studying scientific and legal documents
• Gathering, evaluating, organizing, managing, and collating information in various formats
• Ensuring compliance with regulations set by legal authorities such as Medicines and Medical Devices Regulatory Agency (AEMPS)
• Maintaining familiarity with company product ranges
• Ensuring compliance with regulations set by authorities such as EFSA for Food and Food Supplements
• Keeping up to date with changes in regulatory legislation and guidelines
• Analyzing complex information, including clinical trial data
• Providing advice on company policies, practices, and systems
• Obtaining marketing permissions
• Outlining requirements for labelling, storage, and packaging
• Using various specialist computer applications
• Liaising and negotiating with regulatory authorities
• Advising manufacturers / scientists about regulations
• Writing clear, user-friendly product information leaflets and labels
• Ensuring quality standards are met and submissions are timely
• Preparing necessary documentation

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