Regulatory Affairs Technician

AB-BIOTICS; España; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading biotechnology firm in Spain is seeking a Regulatory Affairs Technician to ensure compliance with regulations and analyze complex scientific documents. The ideal candidate will hold a PhD or Master’s in relevant fields and have 1-2 years of experience in Regulatory Affairs. This full-time position offers a competitive salary based on skills and experience.

Formación

• 1-2 years of experience in Regulatory Affairs.
• Specific training in Regulatory Affairs.

Responsabilidades

• Studying scientific and legal documents.
• Gathering and managing information in various formats.
• Ensuring compliance with regulations from authorities.
• Providing advice on company policies, practices, and systems.

Conocimientos

Technological knowledge

Knowledge of product technical specifications

Experience in Regulatory Affairs

Educación

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

Descripción del empleo

Join to apply for the Regulatory Affairs Technician role at AB-BIOTICS. This position offers a competitive salary range, which will be determined based on your skills and experience. Please discuss with your recruiter for more details.

Requirements

• Technological knowledge (PhD or Master’s degree in molecular biology, biotechnology, pharmacy, biomedicine, or similar)
• Knowledge of product technical specifications
• 1-2 years of experience in 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 from authorities such as AEMPS (Medicines and Medical Devices) and EFSA (Food and Food Supplements)
• Maintaining familiarity with company product ranges
• 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 specialist computer applications
• Liaising and negotiating with regulatory authorities
• Creating clear, user-friendly product information leaflets and labels
• Ensuring quality standards and submission deadlines are met
• Preparing necessary documentation

Employment Type

Full-time

Job Function

Engineering and Information Technology

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