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hace 4 semanas
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:
- 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 4 years in a similar role working in regulatory writing in the 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 work at Asphalion?
Permanent contract.
Home office & Hybrid or Remote Model (You can be located anywhere in Spain)
Wide variety of projects, new challenges, and experiences.
Training and personal development program.
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