Job Overview ASPHALION invites applications for the position of Medical Writer – Regulatory Affairs Senior Officer, joining our dynamic team of experts in development, strategy, and scientific writing. As a senior writer, you will be instrumental in creating and implementing regulatory strategies for our pharmaceutical projects. Main Responsibilities: 1. Create high-quality regulatory documents for drug development, including SA, PIP, ODD, IMPD, and IB. 2. Develop eCTD Dossier clinical and nonclinical documents (M2). 3. Design regulatory roadmaps to guide project success. 4. Collaborate in regulatory strategy for MAA submissions. 5. Build strong relationships with clients, establishing milestones, planning, and executing tasks, managing timelines, and project reporting. 6. Act as liaison between health authorities and our company for drug development procedures. 7. Submit and manage applications through various portals, such as CTIS and IRIS. Key Requirements: 1. Scientific or biomedical educational background. 2. Minimum 4 years of experience in regulatory writing within the pharma sector or equivalent fields. 3. Strong understanding of regulatory affairs. 4. Excellent client-orientation and proactive approach. 5. Proficiency in MS Office Suite. 6. Language: English C1 level or higher, with Spanish being advantageous.