Requirements: English
Company: ASPHALION
Region: espana, espana, espana ,
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: The Medical Writer will be in charge of the timely and correct execution of projects according to defined timelines: 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 3 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 working at Asphalion? Permanent contract. Flexible working schedule - Friday until 15.30h. 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. English lessons. A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship. A highly & dynamic working environment with employees from more than 15 nationalities. Our people and their well-being are our priority: Physical, psychological and emotional well-being programme. Internal activities & RSC Activities Equal Opportunity Employer