Home-based Regulatory Affairs Specialist — CTIS & CTA Lead

Indero; Madrid; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A contract research organization is seeking a Regulatory Affairs Specialist in Madrid. The role involves preparing and submitting regulatory documentation, ensuring compliance with EU regulations, and coordinating timelines for clinical trial submissions. Candidates should have a Bachelor's degree in a scientific discipline and 2-3 years in regulatory affairs. The position offers a permanent full-time contract, a flexible schedule, and home-based work options.

Servicios

Permanent full-time position

Flexible schedule

Vacation

Home-based position

Ongoing learning and development

Formación

• Minimum of 2-3 years of clinical research experience in regulatory affairs.
• Experience in initial CTA is essential.
• Hands-on experience preparing, reviewing, and submitting regulatory documents.

Responsabilidades

• Prepare regulatory documents and submissions to ensure compliance.
• Coordinate regulatory timelines for all assigned projects.
• Serve as point of contact for Sponsors and project management teams.

Conocimientos

Excellent organization and communication skills

Fluency in English

Knowledge of GCP and ICH standards

Attention to detail

Ability to work under pressure

Versatile in multitasking

Educación

Bachelor's degree in a scientific discipline

Descripción del empleo

A contract research organization is seeking a Regulatory Affairs Specialist in Madrid. The role involves preparing and submitting regulatory documentation, ensuring compliance with EU regulations, and coordinating timelines for clinical trial submissions. Candidates should have a Bachelor's degree in a scientific discipline and 2-3 years in regulatory affairs. The position offers a permanent full-time contract, a flexible schedule, and home-based work options.