Regulatory Affairs Technician

AB-Biotics, S.A.; Sevilla; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A biotechnology company in Sevilla is seeking a Regulatory Affairs professional. The ideal candidate will have a relevant PhD or Master’s degree and 1-2 years of experience in Regulatory Affairs. Responsibilities include ensuring compliance with regulations, analyzing complex information, and providing clear product information. Fluency in English, Spanish, and Catalan is required.

Formación

• PhD or Master’s degree in a relevant field.
• 1-2 years experience in Regulatory Affairs.
• Specific training in Regulatory Affairs.

Responsabilidades

• Studying scientific and legal documents.
• Ensuring compliance with regulations by AEMPS and EFSA.
• Analyzing complex information, including clinical trial data.

Conocimientos

Technological knowledge

Languages: English, Spanish & Catalan

Experience in Regulatory Affairs

Specific training in Regulatory Affairs

Educación

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

Descripción del empleo

Qualifications:

• Technological knowledge (PhD or Master’s degree in molecular biology, biotechnology, pharmacy, biomedicine, or similar)
• Knowledge of product technical specifications
• Languages: English, Spanish & Catalan
• Experience of at least 1-2 years in 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 AEMPS and EFSA for Food and Food Supplements
4. Maintaining familiarity with company product ranges
5. Keeping up to date with changes in regulatory legislation and guidelines
6. Analyzing complex information, including clinical trial data
7. Providing advice on company policies, practices, and systems
8. Obtaining marketing permissions
9. Outlining requirements for labelling, storage, and packaging
10. Using various specialist computer applications
11. Liaising and negotiating with regulatory authorities
12. Advising manufacturers and scientists about regulations
13. Writing clear, user-friendly product information leaflets and labels
14. Ensuring quality standards are met and submissions are timely
15. Preparing necessary documentation

Note: The code J-18808-Ljbffr appears to be an internal reference and may not be necessary in the public job description.