Company: ASPHALION
Region: Ourense , Galicia
We are looking for aMedical Writer Regulatory Affairs Senior officerfor 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 backgroundExperience: Minimum of 3 years in a similar role working in regulatory writing in pharma sector, or spin-off /start upSkills 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