Regulatory Affairs Senior Officer - Medical Writer

ASPHALION; Palma de Mallorca; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the pharma sector is seeking a Medical Writer – Regulatory Affairs Senior Officer to join their team. In this role, you will be responsible for writing regulatory documents, preparing eCTD dossiers, and managing relationships with health authorities. The position offers a permanent contract with flexible work options, a variety of projects, and opportunities for personal development.

Servicios

Permanent contract

Home office & hybrid or remote model

Personal development programs

Formación

• Minimum of 3 years in a similar regulatory writing role within the pharma sector.
• Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage.

Responsabilidades

• Writing regulatory documents to support drug development.
• Preparing eCTD dossiers including clinical and nonclinical documents.
• Managing client and partner relationships.

Conocimientos

Client-oriented communication skills

Proactive mindset

Strong knowledge of regulatory affairs

Educación

Scientific or biomedical degree

Herramientas

MS Office Suite

Descripción del empleo

We are looking for a Medical Writer – Regulatory Affairs Senior Officer for our team of development, strategy, and scientific writing experts. Someone who loves science and wants to use their experience in a new, challenging professional step.

Main Responsibilities:

The Medical Writer will be responsible for the timely and accurate execution of projects according to defined timelines:

• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB)
• Preparing eCTD dossiers, including clinical and nonclinical documents (Module 2)
• Designing regulatory roadmaps
• Developing regulatory strategies for Marketing Authorization Applications (MAA)
• Managing client and partner relationships: defining milestones, planning, task execution, managing timelines, and project 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 3 years in a similar regulatory writing role within the pharma sector, or in spin-offs/startups

Skills and Competencies:

Strong knowledge of regulatory affairs, excellent client-oriented communication skills, and a proactive mindset.

Technical Skills: Advanced proficiency in 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 (located anywhere in Spain), a wide variety of projects, new challenges, and personal development programs.