Requirements: English
Company: ASPHALION
Region: Gorguja , Catalonia
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 * Fluent in English (C1) & Spanish * Advanced IT level (MS Office). skills&interest in IT * Proactive, good communication, accurate, detail orientated. Why working at Asphalion? Permanent contract.
Flexible working schedule - Friday until 15.30h.
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. English lessons.
A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship. A highly & dynamic working environment with employees from more than 15 nationalities. Our people and their well-being are our priority: Physical, psychological and emotional well-being programme.
Internal activities & RSC Activities Equal Opportunity Employer