Regulatory Affairs Technician

AB-Biotics, S.A.; Sant Cugat del Vallès; Presencial; EUR 35.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in the biotechnology sector seeks a Regulatory Affairs Specialist to ensure compliance with regulations and manage product submissions. The ideal candidate will have a relevant PhD or Master’s degree, 1-2 years of experience, and strong knowledge of regulatory legislation. Responsibilities include evaluating documentation, maintaining quality standards, and advising on compliance matters.

Formación

• Experience of at least 1-2 years in Regulatory Affairs.
• Specific training in Regulatory Affairs.

Responsabilidades

• Studying scientific and legal documents.
• Gathering and organizing information in various formats.
• Ensuring compliance with regulations set by legal authorities.
• Liaising with regulatory authorities and advising manufacturers.

Conocimientos

Technological knowledge

Product technical specifications knowledge

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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