Regulatory Affairs Senior Officer - Medical Writer

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.