Regulatory Affairs Technician

AB-BIOTICS; Sant Cugat del Vallès; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Sant Cugat del Vallès is seeking a qualified regulatory affairs specialist. Responsibilities include studying scientific documents, ensuring compliance with legal authorities, managing product trials, and negotiating with regulatory bodies. The ideal candidate should have experience in Pharma, OTC, and pharmaceutical registration, and demonstrate strong analytical skills and attention to detail to successfully navigate the complexities of regulatory standards.

Formación

• Experience in preparing documentation and ensuring compliance with regulations.
• Ability to manage product trials and regulatory inspections efficiently.
• Fluency in writing clear product information for various audiences.

Responsabilidades

• Studying scientific and legal documents.
• Gathering and organizing information in various formats.
• Maintaining familiarity with company product ranges.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Writing user-friendly product information leaflets and labels.

Conocimientos

Analyzing complicated information

Liasing with regulatory authorities

Knowledge of legal regulations

Experience in Pharma, OTC and pharmaceutical register

Descripción del empleo

• 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*