Medical Writer – Regulatory Affairs Senior Officer

buscojobs España; Córdoba; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a Medical Writer – Regulatory Affairs Senior Officer. This role involves writing regulatory documents, designing regulatory strategies, and managing client relations. The ideal candidate should have a scientific background and strong knowledge of regulatory affairs. Join a dynamic team offering flexible work arrangements and opportunities for professional growth.

Servicios

Permanent Contract

Home Office & Hybrid or Remote Model

Variety of Projects

Training and Personal Development Programs

Formación

• Minimum of 4 years in a similar regulatory writing role within the pharma sector.

Responsabilidades

• Writing regulatory documents to support drug development.
• Preparing eCTD Dossier clinical/nonclinical documents.
• Managing client and partner relations.

Conocimientos

Regulatory Affairs

Client-oriented Communication

Proactive Mindset

Educación

Scientific or Biomedical Degree

Herramientas

MS Office Suite

Descripción del empleo

We are looking for a Medical Writer – Regulatory Affairs Senior Officer

Join our team of development, strategy, and scientific writing experts. We seek someone passionate about science who wants to take on a new, challenging professional role.

Main Responsibilities:

• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB)
• Preparing eCTD Dossier clinical/nonclinical documents (Module 2)
• Designing regulatory roadmaps
• Developing regulatory strategies for MAA
• Managing client and partner relations: defining milestones, planning, executing tasks, managing timelines, and reporting
• Liaising with health authorities for drug development procedures
• Submitting and managing applications through portals (CTIS, IRIS, etc.)

Requirements:

Educational Background: Scientific or biomedical degree

Experience: Minimum of 4 years in a similar regulatory writing role within the pharma sector, or in spin-offs/start-ups

Skills and Competencies:

• Strong knowledge of regulatory affairs
• Excellent client-oriented communication skills and proactive mindset
• Advanced proficiency in IT tools (MS Office Suite)

Languages: Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage

Why work at Asphalion?

• Permanent contract
• Home office & hybrid or remote model (location flexible across Spain)
• Variety of projects, new challenges, and learning opportunities
• Training and personal development programs