Regulatory Affairs Technician

AB-Biotics, S.A.; Barcelona; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in the biotechnology sector seeks a Regulatory Affairs Specialist to ensure compliance with legal regulations for its products. The role involves analyzing scientific documents, obtaining marketing permissions, and liaising with regulatory authorities. Ideal candidates will have a relevant degree and experience in the field, alongside strong analytical and language skills.

Formación

• Experience in Regulatory Affairs (1-2 years).
• Specific training in Regulatory Affairs.

Responsabilidades

• Studying scientific and legal documents.
• Ensuring compliance with regulations set by legal authorities.
• Preparing necessary documentation.

Conocimientos

Technical knowledge

Product specifications knowledge

Language skills (English, Spanish & Catalan)

Educación

PhD or Master’s degree in molecular biology, biotechnology, pharmacy, biomedicine, or similar

Descripción del empleo

• 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 :

• Studying 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

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