**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
- 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