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. The ideal candidate will have a passion for science and experience in regulatory writing within the pharmaceutical sector. Main Responsibilities: - Developing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB) - Creating eCTD Dossier clinical/nonclinical documents (M2) - Designing regulatory roadmaps - Formulating regulatory strategies for MAA - Managing client relationships, defining milestones, planning tasks, and executing projects - Liaising with health authorities for drug development procedures - Submitting and managing applications through portals (CTIS, IRIS, ...) Requirements: - A scientific or biomedical background - Minimum 4 years of experience in a similar role within the pharma sector or spin-off/startup - Strong knowledge of regulatory affairs - Excellent communication skills and a proactive mindset - Advanced proficiency in IT tools (MS Office Suite) - Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage