Regulatory Affairs Senior Officer - Medical Writer

We are seeking a Medical Writer – Regulatory Affairs Senior Officer for our team of development, strategy, and scientific writing experts. This role is ideal for someone passionate about science and eager to advance their career in a new, challenging environment.

Main Responsibilities:

• Ensure the timely and accurate execution of projects according to defined timelines.
• Write regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
• Prepare eCTD dossier clinical/nonclinical documents (Module 2).
• Design regulatory roadmaps and strategies for MAA.
• Manage client and partner relationships: define milestones, plan and execute tasks, manage timelines, and report on projects.
• Coordinate with health authorities for drug development procedures.
• Handle submissions and application management through portals (CTIS, IRIS, etc.).

Requirements:

• Educational Background: Scientific or biomedical degree.
• Experience: Minimum of 3 years in regulatory writing within the pharma sector, or in a spin-off/start-up environment.
• Skills and Competencies: Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset.
• IT 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 work model (located anywhere in Spain).
• Variety of projects, new challenges, and learning opportunities.
• Training and personal development programs.