Medical Writer – Regulatory Affairs Senior Officer
hace 7 días
We are looking for aMedical Writer – Regulatory Affairs Senior Officerfor our team of development, strategy, and scientific writing experts.
This role is ideal for someone passionate about science and eager to leverage their experience in a new, challenging professional environment.
Main Responsibilities :Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
Preparing eCTD dossier clinical/nonclinical documents (M2).
Designing regulatory roadmaps.
Developing regulatory strategies for MAA.
Managing client and partner relationships: defining milestones, planning, executing tasks, managing timelines, and project reporting.
Communicating with health authorities regarding drug development procedures.
Submitting and managing applications through portals (CTIS, IRIS, etc.).
Requirements :Educational Background :Scientific or biomedical background.
Experience : Minimum of 4 years in a similar regulatory writing role within the pharma sector, or in spin-offs/startups.
Skills and Competencies :Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset.
Technical Skills :Advanced proficiency in IT tools (MS Office Suite).
Languages : Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage.
Why work at Asphalion?Permanent contract.
Home office & hybrid or remote model (located anywhere in Spain).
Variety of projects, new challenges, and experiences.
Training and personal development programs.
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