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Regulatory Affairs Technician
AB-Biotics, S.A.barcelona, EspañaHace más de 30 días
Descripción del trabajoStudying 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
Education :
- Technological knowledge (PhD or Master’s degree in molecular biology, biotechnology, pharmacy, biomedicine, or similar)
- Product technical specifications knowledge
- Languages knowledge (English, Spanish & Catalan)
Experience of at least 1-2 years in the field of Regulatory Affairs
Specific training in Regulatory Affairs
Main responsibilities :
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Regulatory Technician • barcelona, España