Regulatory Affairs Technician

AB-BIOTICS; Barcelona; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

AB-BIOTICS is seeking a Regulatory Affairs Technician to manage and ensure compliance with regulations for its products. Candidates should possess a relevant PhD or Master's degree and experience in the field. The role involves analyzing scientific documents, maintaining regulatory familiarity, and preparing product information. Join a dynamic team focused on maintaining high-quality standards in biotechnology.

Formación

• 2 years experience in Regulatory Affairs preferred.
• Training in Regulatory Affairs required.
• Ability to analyze complex information.

Responsabilidades

• Studying scientific and legal documents.
• Gathering and managing regulatory information.
• Ensuring compliance with AEMPS and EFSA regulations.

Conocimientos

Knowledge of product technical specifications

Technological knowledge

Regulatory compliance

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

Referrals can increase your chances of interviewing at AB-BIOTICS by 2x.

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