eSubmission – Regulatory Affairs Officer

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.