Regulatory Affairs Technician

AB-Biotics, S.A.; Sant Cugat del Vallès; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

A biotech company in Sant Cugat del Vallès is seeking a Regulatory Affairs Specialist responsible for ensuring compliance with regulations, overseeing product trials, and managing documentation. The ideal candidate will have experience in studying scientific and legal documents and analyzing clinical trial data. This role requires keeping up to date with changes in regulatory guidelines and liaising with regulatory authorities to obtain marketing permissions.

Formación

• Experience in studying scientific and legal documents.
• Familiarity with regulatory compliance and standards.
• Ability to analyze complex clinical trial data.

Responsabilidades

• Study scientific and legal documents to ensure compliance.
• Manage and collate information in various formats.
• Plan and oversee product trials and regulatory inspections.

Descripción del empleo

Responsibilities

• Studying scientific and legal documents
• Gathering, evaluation, organizing, managing and collating information in a variety of formats.
• Ensuring compliance with regulations set by the legal authorities as Medicines and Medical devices Regulatory Agency (AEMPS)
• Maintaining familiarity with company product ranges
• Planning, undertaking, and overseeing product trials and regulatory inspections
• Keeping up to date with changes in regulatory legislation and guidelines
• Analyzing complicated information, including clinical trial data
• Offering advice about company policies, practices and systems
• Obtaining marketing permission
• Outlining requirements for labelling, storage and packaging
• Using a variety of specialist computer applications
• Liasing and negotiating with regulatory authorities
• Providing advice about regulations to manufacturers / scientists
• Writing comprehensible, user-friendly, clear product information leaflets and labels
• Ensuring that quality standards are met and submissions meet strict deadlines
• Preparing documentation
• Experience in Pharma, OTC and pharmaceutical register