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 leverage 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 Dossier clinical/nonclinical documents (Module 2)
• Designing regulatory roadmaps
• Developing regulatory strategies for MAA
• Managing clients and partners: defining milestones, planning and 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 3 years in a similar regulatory writing role within the pharma sector, spin-offs, or startups

Skills and Competencies:

Strong knowledge of regulatory affairs.

Excellent client-oriented communication skills and a proactive mindset.

Advanced proficiency in IT tools (MS Office Suite).

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

Why work at Asphalion?

Permanent contract.

Home office & hybrid or remote model (you can be located anywhere in Spain!).

Wide variety of projects, new challenges, and experiences.

Training and personal development programs.