Regulatory Affairs Technician

AB-BIOTICS; Sant Cugat del Vallès; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

AB-BIOTICS is seeking a Regulatory Affairs Technician to ensure compliance with regulations such as AEMPS and EFSA. The position requires a strong background in molecular biology or similar fields, with 1-2 years of experience in Regulatory Affairs. Responsibilities include analyzing documentation, managing product information, and liaising with regulatory authorities. This full-time role offers competitive salary conditions based on the applicant's expertise.

Formación

• 1-2 years of experience in Regulatory Affairs is required.
• Specific training in Regulatory Affairs is necessary.
• Familiarity with regulatory authorities such as AEMPS and EFSA is advantageous.

Responsabilidades

• Studying scientific and legal documents to ensure compliance.
• Gathering and managing information in various formats.
• Liaising with regulatory authorities to obtain marketing permissions.

Conocimientos

Technological knowledge

Knowledge of product technical specifications

Ability to analyze complex information

Educación

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

Herramientas

Specialist computer applications

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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