eSubmission – Regulatory Affairs Officer

ASPHALION; Tarragona; Híbrido; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry is seeking a Regulatory Affairs professional to join their vibrant team. The role involves preparing regulatory submissions worldwide, managing electronic dossiers, and keeping up with regulatory updates. With a permanent contract and a hybrid work model, this opportunity offers a diverse range of projects and a commitment to your professional development.

Servicios

Training and personal development program

Wide variety of projects and new challenges

Formación

• Experience in Regulatory Affairs / eSubmission Pharma departments.
• Experience in eCTD and publishing tools in EU and US.
• Advanced IT skills and interest in IT.

Responsabilidades

• Preparation of submissions in eCTD or NeeS format.
• Regulatory Affairs for submissions in the EU and FDA.
• Consolidation and migration of submission dossiers.

Conocimientos

Proactive

Good communication

Detail oriented

Educación

Life Science Degree

Herramientas

eCTD Manager

DocuBridge

Veeva

Descripción del empleo

Are you excited about the information technology and the pharmaceutical industry? Ready to learn and grow in regulatory affairs? Do you want to be a part of a vibrant and international team? We're looking for someone eager to tackle new challenges, excel in a global environment, and grow with us!

Main responsibilities :

• Preparation of submissions in eCTD or NeeS format to different regions and procedures worldwide, including (but not restricted) : EU, US, CH
• Regulatory Affairs for Submissions in EU and FDA (initial applications and maintenance activities)
• Submission of dossier by electronic means (EMA Gateway, CESP, etc)
• Publishing applications and submitting them to the relevant Health Authorities via portals
• Consolidation and migration of submission dossiers in the electronic system
• keeping up to date with the telematic regulatory updates
• Reviewing sequences and providing technical support for colleagues and local teams

Requirements :

• Experience in Regulatory Affairs / eSubmission Pharma departments.
• Experience in eCTD and publishing tools (e.g. Ectd Manager, DocuBridge or Veeva) in EU and US.
• Life Science Degree
• Advanced IT level – (MS Office). skills&interest in IT
• Proactive, good communication, accurate, detail orientated.

Why working at Asphalion?

Permanent contract.

Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain!)

Wide variety of projects, new challenges and experiences.

Training and personal development program.