We are looking for a Medical Writer – Regulatory Affairs Senior officer for our team of development, strategy and scientific writing expert unit. Someone who loves Science and wants to use their experience in a new challenging professional step. Main Responsibilities: Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB) Writing eCTD Dossier clinical / nonclinical documents (M2) Design of regulatory roadmaps Regulatory strategy for MAA Client and partner management: define milestones, planning and execution of tasks, manage timelines, project reporting Liaison with health authorities for drug development procedures Submission and management of applications through portals (CTIS, IRIS, ...) Requirements: Educational Background: Scientific / biomedical background Experience: Minimum of 4 years in a similar role working in regulatory writing in pharma sector, or spin-off / start up Skills and Competencies: Strong knowledge of regulatory affairs. Excellent client-oriented communication skills and proactive mindset. Advanced proficiency in IT tools (MS Office Suite). Languages: Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage. Why work at Asphalion? Permanent contract. Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain!) Wide variety of projects, new challenges and experiences. Training and personal development program. #J-18808-Ljbffr