Regulatory Affairs Technician

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

Descripción de la vacante

A biotechnology company in Spain is seeking a Regulatory Affairs specialist with a PhD or Master’s in a relevant field. Key responsibilities include ensuring compliance with regulations and analyzing complex clinical data. Candidates should have at least 1-2 years of experience and be fluent in English, Spanish, and Catalan. The ideal candidate will also be capable of preparing documentation and maintaining product specifications.

Formación

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

Responsabilidades

• Studying scientific and legal documents.
• Ensuring compliance with regulations from authorities.
• Analyzing complex information, including clinical trial data.
• Obtaining marketing permissions.
• Writing clear, user-friendly product information leaflets.

Conocimientos

Technical knowledge in molecular biology

Product technical specifications knowledge

Languages knowledge (English, Spanish, Catalan)

Analytical skills for complex information

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:

1. Studying scientific and legal documents
2. Gathering, evaluating, organizing, managing, and collating information in various formats
3. Ensuring compliance with regulations set by legal authorities such as Medicines and Medical Devices Regulatory Agency (AEMPS)
4. Maintaining familiarity with company product ranges
5. Ensuring compliance with regulations set by authorities such as EFSA for Food and Food Supplements
6. Keeping up to date with changes in regulatory legislation and guidelines
7. Analyzing complex information, including clinical trial data
8. Providing advice on company policies, practices, and systems
9. Obtaining marketing permissions
10. Outlining requirements for labelling, storage, and packaging
11. Using various specialist computer applications
12. Liaising and negotiating with regulatory authorities
13. Advising manufacturers/scientists about regulations
14. Writing clear, user-friendly product information leaflets and labels
15. Ensuring quality standards are met and submissions are timely
16. Preparing necessary documentation

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