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 Affairs
Specific training in Regulatory Affairs
Main 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 documentation