Regulatory Affairs Senior Officer - Medical Writer

We are looking for a Medical Writer – Regulatory Affairs Senior Officer to join our team of development, strategy, and scientific writing experts. If you love science and want to take your experience to a new professional level, this opportunity is for you.

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, task execution, 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, or spin-off/start-up environment

Skills and competencies:

Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset, and advanced proficiency in IT tools (MS Office Suite).

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

Why work at Asphalion?

Permanent contract, home office & hybrid or remote model (anywhere in Spain), a wide variety of projects, new challenges, training, and personal development opportunities.