eSubmission – Regulatory Affairs Officer

ASPHALION; Jerez de la Frontera; A distancia; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

ASPHALION is seeking a Regulatory Affairs professional to join their vibrant team. The role involves preparing submissions in eCTD format for various regions, managing regulatory affairs for EU and FDA submissions, and providing technical support. The position offers a permanent contract with flexible working hours and opportunities for personal development.

Servicios

Permanent contract

Flexible working schedule

Home office & hybrid model

Training and personal development program

Well-being programs

Formación

• Experience in Regulatory Affairs / eSubmission Pharma departments.
• Fluent in English (C1) and Spanish.
• Proactive, good communication, accurate, detail-oriented.

Responsabilidades

• Preparation of submissions in eCTD or NeeS format to different regions.
• Regulatory Affairs for Submissions in EU and FDA.
• Consolidation and migration of submission dossiers in electronic systems.

Conocimientos

Regulatory Affairs

eCTD

Publishing tools

IT skills

Communication

Detail-oriented

Educación

Life Science Degree

Herramientas

Ectd Manager

DocuBridge

Veeva

MS Office

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 :

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 dossiers by electronic means (EMA Gateway, CESP, etc.).
4. Publishing applications and submitting them to relevant Health Authorities via portals.
5. Consolidation and migration of submission dossiers in electronic systems, keeping up to date with telematic regulatory updates.
6. Reviewing sequences and providing technical support for colleagues and local teams.

Requirements :

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

Why work at Asphalion?

• Permanent contract.
• Flexible working schedule - Friday until 15:30.
• Home office & hybrid or remote model.
• Location: Anywhere in Spain.
• Wide variety of projects, new challenges, and experiences.
• Training and personal development program, including English lessons.
• Inclusive, high-performance work environment to develop your skills and grow your career.
• Company culture built around Passion, Flexibility, Commitment, Quality & Camaraderie.
• International environment with employees from over 15 nationalities.
• Well-being programs: physical, psychological, and emotional.
• Internal activities & RSC activities.
• Equal Opportunity Employer.