Regulatory Affairs Technician

Job title:

Regulatory Affairs Technician

Company:

AB-Biotics, S.A.

Job description

Education:

• Technologic 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 year in the field of Regulatory AffairsSpecific training in Regulatory AffairsMain responsabilities: Studying scientific and legal documents Gathering, evaluating, organizing, managing, and collating information in a variety of formats Ensuring compliance with regulations set by the legal authorities as Medicines and Medical devices Regulatory agency (AEMPS) Maintaining familiarity with company product ranges Ensuring compliance with regulations set by the legal authorities as Food and Food Supplements (EFSA) Keeping up to date with changes in regulatory legislation and guidelines Analyzing complicated information, including clinical trial data Offering advice about company policies, practices, and systems Obtaining marketing permission Outlining requirements for labelling, storage, and packaging Using a variety of specialist computer applications Liaising and negotiating with regulatory authorities Providing advice about regulations to manufacturers/scientists Writhing comprehensible, user-friendly, clear product information leaflets and labels Ensuring that quality standards are met, and submissions meet strict deadlines Preparing documentationAB-Biotics, S.A.

Expected salary

Location

Sant Cugat del Vallès, Barcelona

Job date

Mon, 26 May 2025 22:21:38 GMT

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