Regulatory Affairs Technician
Regulatory Affairs Technician
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EUR 25 - 35
1 Vacancy
Job Description
Education:
* Technologic knowledge (PhD or Masters degree in molecular biology biotechnology pharmacy biomedicine or similar)
* Product technical specifications knowledge
* Languages knowledge (English Spanish & Catalan)
Experience of at least 12 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 userfriendly clear product information leaflets and labels
Ensuring that quality standards are met and submissions meet strict deadlines
Preparing documentation
Employment Type
Full Time
