Regulatory Affairs Senior Officer - Medical Writer

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

Senior Medical Writer • Lugo, Galicia, Spain