Job Description We are seeking a highly skilled Medical Writer – Regulatory Affairs Senior Officer to join our team of development, strategy and scientific writing experts. As a key member of our unit, you will play a crucial role in shaping the regulatory landscape for our pharmaceutical projects. Main Responsibilities: 1. Develop high-quality regulatory documents to support drug development, including SA, PIP, ODD, IMPD, and IB. 2. Create eCTD Dossier clinical and nonclinical documents (M2). 3. Contribute to regulatory strategy for MAA submissions. 4. Manage client relationships, defining milestones, planning, and executing tasks, managing timelines, and project reporting. 5. Serve as liaison with health authorities for drug development procedures. 6. Submit and manage applications through portals such as CTIS and IRIS. Requirements: 1. Hold a Scientific or Biomedical background. 2. Possess a minimum of 4 years' experience in a similar role, working in regulatory writing within the pharma sector, or spin-off/start-up. 3. Demonstrate strong knowledge of regulatory affairs. 4. Excel in client-oriented communication skills and proactive mindset. 5. Exhibit advanced proficiency in IT tools (MS Office Suite). 6. Languages: Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage. Why work at ASPHALION? 1. Pursue a permanent contract. 2. Benefit from home office and hybrid or remote model flexibility. 3. Engage in a wide variety of projects, new challenges, and experiences. 4. Participate in a comprehensive training and personal development program.