Junior Regulatory Affairs Officer - Esubmission

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 :

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

Requirements :

1. Experience in Regulatory Affairs / eSubmission Pharma departments.
2. Experience or interest in eCTD and publishing tools (e.g., Ectd Manager, DocuBridge or Veeva) in EU and US.
3. Life Science Degree
4. Fluent in English (C1) & Spanish
5. Advanced IT skills – (MS Office), interest in IT
6. Proactive, good communication, accurate, detail-oriented

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

Regulatory Officer • Tarragona, Kingdom Of Spain, ES